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Glofitamab

  • Antibody medicine
  • Still being tested
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Glofitamab does in the body

COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

From the FDA-approved label: Glofitamab-gxbm is a bispecific antibody that binds to CD20 expressed on the surface of B cells, and to CD3 receptor expressed on the surface of T cells. Glofitamab-gxbm causes T-cell activation and proliferation, secretion of cytokines, and the lysis of CD20-expressing B cells. Glofitamab-gxbm showed anti-tumor activity in vivo in mouse models of DLBCL.

Why people take it. COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as protein.

    FDA substance registry · 06P3KLK2J8 · read 2026-08-29

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 147 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Progression-free survival (PFS) as determined by Independent Review Facility (IRF)

The study did not show it

Who was studied
NCT06047080
How many people
1130
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs)

The study did not show it

Who was studied
NCT03075696
How many people
940
Study design
Phase 1/Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Nature and frequency of dose-limiting toxicities (DLTs)

The study did not show it

Who was studied
NCT04077723
How many people
498
Study design
Phase 1/Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Number of participants with adverse events (AEs)

The study did not show it

Who was studied
NCT06090539
How many people
460
Study design
Phase 1/Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Progression free survival (PFS) (cohort 1) (phase II)

The study did not show it

Who was studied
NCT07724457
How many people
271
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Overall survival (OS), defined as the time from randomization to date of death from any cause

The study did not show it

Who was studied
NCT04408638
How many people
270
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.6 registered measures of this kind. 3 written-up studies measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health No evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

No registered study measured anything of this kind.

Meaningful

Things that change how a life goes, not only a number.

  • progression free survival
  • overall survival
  • deaths due to adverse events
  • progression free survival rate
  • real world progression free survival
  • event free survival

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (34)
  • part i and ii percentage of dose limiting toxicities
  • part i ii and iii percentage of adverse events
  • part i percentage of dose limiting toxicities
  • part i and ii percentage of adverse events
  • dose limiting toxicities
  • nature and frequency of dose limiting toxicities
  • adverse event
  • overall response rate
  • disease control rate
  • duration of response
  • complete response
  • incidence of adverse events
  • treatment discontinuations due to ae
  • serious adverse events
  • cytokine release syndrome by grade of severity
  • adverse events
  • anti drug antibodies
  • end of treatment complete metabolic response rate
  • complete response rate
  • incidence of dose limiting toxicity

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What it would be like to takeRead from sources, not yet reviewed

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 7.6 days

    Read from the label, which states: “Elimination At steady state, the glofitamab-gxbm terminal half-life is 7.6 days (24%) and the clearance is 0.617 L/day (33%).”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1) ].

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and efficacy of COLUMVI in pediatric patients have not been established.”

    US prescribing information · 3516e753-f064-4d30-9bd5-e3f2e143f75d · read 2026-08-30

  • On older people, the label states: “Of the 145 patients with relapsed or refractory LBCL who received COLUMVI in study NP30179, 55% were 65 years of age or older, and 23% were 75 years of age or older.”

    US prescribing information · 3516e753-f064-4d30-9bd5-e3f2e143f75d · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action COLUMVI may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .”

    US prescribing information · 3516e753-f064-4d30-9bd5-e3f2e143f75d · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of glofitamab-gxbm in human milk or the effects on the breastfed child or milk production.”

    US prescribing information · 3516e753-f064-4d30-9bd5-e3f2e143f75d · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Still being tested

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Intravenous

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S3, S4, S6.

No source is stored against this line.

What is in the pack

Sold as concentrate, solution, concentrate, given by the intravenous route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Glofitamab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 286 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • cytokine release syndrome — 89 reaction mentions
  • disease progression — 48 reaction mentions
  • pyrexia — 27 reaction mentions
  • neutropenia — 24 reaction mentions
  • anaemia — 19 reaction mentions
  • immune effector cell-associated neurotoxicity syndrome — 19 reaction mentions
  • covid-19 — 17 reaction mentions
  • alanine aminotransferase increased — 16 reaction mentions
  • aspartate aminotransferase increased — 14 reaction mentions
  • thrombocytopenia — 13 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Intravenous

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 2 products list this as an active ingredient in the United States drug directory. 2 of them contain it and nothing else.

    FDA National Drug Code directory · 50242-127 · read 2026-08-29

  • They are sold as concentrate and solution, concentrate, taken intravenous.

    FDA National Drug Code directory · 50242-127 · read 2026-08-29

  • The regulator's established pharmacologic class for it is bispecific cd20-directed cd3 t cell engager [epc], cd20-directed antibody interactions [moa] and cd3 receptor agonists [moa].

    FDA National Drug Code directory · 50242-127 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 3516e753-f064-4d30-9bd5-e3f2e143f75d · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 3516e753-f064-4d30-9bd5-e3f2e143f75d · read 2026-08-29

  • Columvi is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 2.5 mg/2.5 mL (1 mg/mL) clear, colorless solution in a single-dose vial. 10 mg/10 mL (1 mg/mL) clear, colorless solution in a single-dose vial., recorded as fda label in effect 2026-06-25 in the United States.

    US prescribing information · 3516e753-f064-4d30-9bd5-e3f2e143f75d · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Glofitamab studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Where else this substance is registered

FDA substance identifier (UNII)
06P3KLK2J8
RxNorm concept
2639786

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S3, S4, S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • The earliest marketing start date recorded for a listed product is 20230615.

    FDA National Drug Code directory · 50242-127 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

6 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
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The record as stored

The full record, for auditing

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Recorded evidence blocks (10)

What did Glofitamab's largest trial (1130 people) and its longest (13 years) measure?

1130 people in Glofitamab's largest registered study, 13 years in its longest registered window, measuring Part I, II and III: Area Under the Serum Concentration Versus Time Curve (AUC) of Glofitamab. ClinicalTrials.gov · 2026-09-01

51 phase2, 23 phase1, 6 na or unstated, 4 phase3, 1 early phase1; NCT05833763; 2037-04; no ageing endpoint recorded. Last human test completed 2025, NCT05364424.

Interpretation These counts include studies where Glofitamab was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase2
    51
  • phase1
    23
  • na or unstated
    6
  • phase3
    4
  • early phase1
    1
  • Last recorded human test NCT05364424
    2025-10-15

recorded 2026-09-01 · last checked 2026-09-04

Glofitamab was tested only in human — what did it show?

human: biomarker (75): the rungs where Glofitamab has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Part I, II and III: Area Under the Serum Concentration Versus Time Curve (AUC) of Glofitamab — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT03075696
    biomarker; Part I, II and III: Area Under the Serum Concentration Versus Time Curve (AUC) of Glofitamab; 75

recorded 2026-09-01 · last checked 2026-09-04

4 of Glofitamab's trials stopped: safety, funding/business, other?

safety (1), funding/business (1) and other (2): Glofitamab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"The study was terminated due to sponsor portfolio re-alignment."; 4 of 75 registered studies

Show the evidence

Trial

  • NCT05219513
    terminated; "The study was terminated due to sponsor portfolio re-alignment."
  • NCT05896163
    terminated; "Business/Administrative decision to pursue other programs/assets within the oncology portfolio. Not due to any detected safety signals or requests from regulatory authorities."
  • NCT06670105
    withdrawn; "PI Request"
  • NCT06922604
    suspended; "Pending Amendment Approval"

recorded 2026-09-01 · last checked 2026-09-04

Glofitamab's half-life is 7.6 days — which schedules were studied?

7.6 days, the half-life Glofitamab's label states. openfda-label · 3516e753-f064-4d30-9bd5-e3f2e143f75d · 2026-08-30

Show the evidence
  • half life
    7.6 days; Elimination At steady state, the glofitamab-gxbm terminal half-life is 7.6 days (24%) and the clearance is 0.617 L/day (33%).
  • metabolism
    Metabolism Glofitamab-gxbm is expected to be metabolized into small peptides by catabolic pathways.

recorded 2026-08-30 · last checked 2026-09-04

Which of adverse event, adverse events and anti drug antibodies did Glofitamab's trials measure?

adverse event, adverse events and anti drug antibodies lead 40 outcome terms across Glofitamab's trials. ClinicalTrials.gov · 2026-09-01

Interpretation part i and ii percentage of adverse events, dose limiting toxicities, nature and frequency of dose limiting toxicities, adverse event, overall response rate and disease control rate follow.

Show the evidence
  • part i and ii percentage of dose limiting toxicities
    1
  • part i ii and iii percentage of adverse events
    1
  • part i percentage of dose limiting toxicities
    1
  • part i and ii percentage of adverse events
    1
  • dose limiting toxicities
    1
  • nature and frequency of dose limiting toxicities
    1
14 more recorded rows
  • adverse event
    1
  • overall response rate
    1
  • disease control rate
    1
  • duration of response
    1
  • progression free survival
    1
  • overall survival
    1
  • complete response
    1
  • incidence of adverse events
    1
  • deaths due to adverse events
    1
  • treatment discontinuations due to ae
    1
  • serious adverse events
    1
  • cytokine release syndrome by grade of severity
    1
  • adverse events
    1
  • anti drug antibodies
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Glofitamab's 64 ongoing trials reports first?

64 registered trials of Glofitamab are open; earliest completion 2026-07-31. ClinicalTrials.gov · 2026-09-01

Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs); Best Objective Response Rate (ORR) as Measured by Independent Review Committee (IRC); latest 2037-04

Show the evidence

Trial

  • NCT03075696
    "A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma"; n 940; "Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs)"; 2029-03-30
  • NCT03533283
    "An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma"; n 211; "Best Objective Response Rate (ORR) as Measured by Independent Review Committee (IRC)"; 2026-10-16
  • NCT04077723
    "A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma"; n 498; "Nature and frequency of dose-limiting toxicities (DLTs)"; 2027-03-31
  • NCT04161248
    "Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma"; n 40; "Establish maximum tolerated dose of new combination therapy"; 2026-12-31
  • NCT04231877
    "Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma"; n 56; "Incidence of adverse events"; 2031-12-01
  • NCT04408638
    "A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma"; n 270; "Overall survival (OS), defined as the time from randomization to date of death from any cause"; 2028-03-31
14 further recorded trials
  • NCT04889716
    "CAR-T Followed by Bispecific Antibodies"; n 23; "Assessment of the percentage of subjects who achieve a complete metabolic response at 24 weeks from date of first infusion as measured by Cheson 14 (ie Lugano) criteria"; 2028-12-31
  • NCT04970901
    "A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)"; n 154; "Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)"; 2028-04-30
  • NCT04980222
    "A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma"; n 46; "End of Treatment Complete Response (EOT CR) Rate"; 2026-09-30
  • NCT05533775
    "A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma"; n 65; "Achievement of a complete response (CR) as determined by the investigator according to the International Pediatric NHL Response Criteria for pediatric participants and Lugano Classification for young adult participants (Arm A)"; 2032-11-30
  • NCT05783596
    "Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma"; n 47; "End of Treatment (EOT) Complete Metabolic Response (CMR) Rate"; 2029-08
  • NCT05798156
    "Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP"; n 125; "1 year progression-free survival (PFS) rate of the first 80 patients"; 2028-02-28
  • NCT05800366
    "A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma"; n 41; "Complete Response (CR) Rate"; 2029-09-15
  • NCT05833763
    "A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure."; n 42; "To evaluate the efficacy of combination Pirtobrutinib and Glofitmab in patients with relapsed/refractory MCL and prior BTK inhibitor exposure."; 2037-04
  • NCT05861050
    "Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma"; n 50; "Progression free survival (PFS)"; 2027-02-01
  • NCT06043674
    "Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation"; n 70; "Best Complete Response (CR) Rate"; 2033-01-15
  • NCT06047080
    "An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma"; n 1130; "Progression-free survival (PFS) as determined by Independent Review Facility (IRF)"; 2030-10-30
  • NCT06050694
    "Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL)"; n 40; "To demonstrate the feasibility of a ctDNA and FDG-PET interim response adapted approach (iRAAp) for the primary therapy of DLBCL"; 2027-11
  • NCT06054776
    "Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma"; n 40; "Incidence of unacceptable adverse events (AEs) (safety lead-in)"; 2026-10-16
  • NCT06071871
    "A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma"; n 99; "Part 1: Overall Response Rate (ORR) to Pola-Glofit as bridging prior to CAR-T cell infusion"; 2028-07-30

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Glofitamab could settle lifespan?

NCT07012980 measures progression-free survival (PFS) rate, reading out 2026-07-31.

13 open trials; n 38; "Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL"

Show the evidence

Trial

  • NCT07012980
    "Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL"; n 38; "progression-free survival (PFS) rate"; 2026-07-31
  • NCT05861050
    "Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma"; n 50; "Progression free survival (PFS)"; 2027-02-01
  • NCT05798156
    "Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP"; n 125; "1 year progression-free survival (PFS) rate of the first 80 patients"; 2028-02-28
  • NCT04408638
    "A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma"; n 270; "Overall survival (OS), defined as the time from randomization to date of death from any cause"; 2028-03-31
  • NCT06084936
    "A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma"; n 182; "Progression-free survival (PFS)"; 2028-03-31
  • NCT06656234
    "The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study"; n 200; "Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma"; 2028-09-15
7 further recorded trials
  • NCT06552572
    "Glofitamab in Relapsed or Refractory Diffuse Large B-cell Lymphoma After CD19 Chimeric Antigen Receptor T-cell Therapy"; n 30; "1-year progression free survival rate after enrollment"; 2028-12-30
  • NCT07200375
    "An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma"; n 300; "real-world Progression-Free Survival (rwPFS)"; 2029-09-29
  • NCT07594899
    "AI-Driven Treatment Strategy vs Pola-R-CHP in Untreated LBCL"; n 178; "Progression-free survival"; 2029-12-31
  • NCT07717177
    "AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL"; n 112; "Progression-free survival"; 2029-12-31
  • NCT06047080
    "An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma"; n 1130; "Progression-free survival (PFS) as determined by Independent Review Facility (IRF)"; 2030-10-30
  • NCT07599423
    "A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma"; n 96; "Event-Free Survival (EFS)"; 2030-12-31
  • NCT07724457
    "Testing the Addition of a New Anti-Cancer Drug, Glofitamab to Usual Chemotherapy for Burkitt and Double Hit Lymphoma"; n 271; "Progression free survival (PFS) (cohort 1) (phase II)"; 2033-11-01

Which one trial of Glofitamab posted no result?

Posted no result
1 of 1 completed trials
Registrations
NCT04657302
Completion dates
oldest 2024-01-12
Show the evidence
  • Trial NCT04657302
    2024-01-12

At the median, Glofitamab's trials enrolled 43 people — anything larger?

Median enrolment
43
Largest enrolment
1130
Registered trials counted
75

What do 286 spontaneous reports say about Glofitamab — and not say?

These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Glofitamab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 286 reaction mentions were counted: cytokine release syndrome 89; disease progression 48; pyrexia 27; neutropenia 24. open-targets-adr · CHEMBL4298092 · 2026-06-24

Show the evidence
  • cytokine release syndrome
    89
  • disease progression
    48
  • pyrexia
    27
  • neutropenia
    24
  • anaemia
    19
  • immune effector cell-associated neurotoxicity syndrome
    19
4 more recorded rows
  • covid-19
    17
  • alanine aminotransferase increased
    16
  • aspartate aminotransferase increased
    14
  • thrombocytopenia
    13

recorded 2026-06-24 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL4298092
CAS number
2229047-91-8
RxCUI
2639786
Also called
Columvi, Glofitamab-gxbm, Ro7082859, glofit, ANTI-CD20/CD3 BISPECIFIC MONOCLONAL ANTIBODY RO7082859, GLOFITAMAB [USAN], Glofitamab [MI], Glofitamab [WHO-DD], Glofitamab gxbm [WHO-DD], IMMUNOGLOBULIN G1 (149-GLUTAMIC ACID,215-GLUTAMIC ACID,461-ALANINE,462-ALANINE,556-GLYCINE,581-CYSTEINE,593-TRYPTOPHAN), ANTI-(HUMAN CD20 ANTIGEN) (HUMAN-MUS MUSCULUS MONOCLONAL RG6026 VH-CH1 FRAGMENT) FUSION PROTEIN WITH PEPTIDE (SYNTHETIC 10-AMINO ACID LINKER) FUSION PROTEIN WITH IMMUNOGLOBULIN ANTI-(HUMAN CD3 ANTIGEN .EPSILON.-CHAIN) (HUMAN-MUS MUSCULUS MONOCLONAL RG6026 HEAVY CHAIN VL(.LAMBDA.)-CH1-CH2-CH3), (222->219''')-DISULFIDE WITH IMMUNOGLOBULIN ANTI-(HUMAN CD20 ANTIGEN) (HUMAN-MUS MUSCULUS MONOCLONAL RG6026 .KAPPA.-CHAIN (128-ARGININE,129-LYSINE)) AND (447->232'')-DISULFIDE WITH IMMUNOGLOBULIN ANTI-(HUMAN CD3 ANTIGEN .EPSILON.-CHAIN) (HUMAN-MUS MUSCULUS MONOCLONAL RG6026 LIGHT CHAIN VH-CL(.KAPPA.)), (453->228'), (456->231'), (581->351')-TRIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (149-GLUTAMIC ACID,215-GLUTAMIC ACID,236-ALANINE,237-ALANINE,331-GLYCINE,351-CYSTEINE,368-SERINE,370-ALANINE,409-VALINE) ANTI-(HUMAN CD20 ANTIGEN) (HUMAN-MUS MUSCULUS MONOCLONAL RG6026 .GAMMA.1-CHAIN) DISULFIDE WITH HUMAN-MUS MUSCULUS MONOCLONAL RG6026 .KAPPA.-CHAIN (128-ARGININE,129-LYSINE), IMMUNOGLOBULIN G1-LAMBDA/KAPPA WITH DOMAIN CROSS-OVER, ANTI-(HOMO SAPIENS MS4A1 (MEMBRANE-SPANNING 4-DOMAINS SUBFAMILY A MEMBER 1, CD20)) AND ANTI-(HOMO SAPIENS CD3E (CD3 EPSILON, LEU-4)) MONOCLONAL ANTIBODY, BISPECIFIC, TRIVALENTGAMMA-LAMBDA HEAVY CHAIN ANTI-MS4A1 AND ANTI-CD3E (VH-CH1-V-LAMBDA-CH1-CH2-CH3) (1-674) (HUMANIZED VH ANTI-MS4A1 (HOMO SAPIENS IGHV1-69*02 (84.7%)-(IGHD)-IGHJ4*01 (100%)) (8.8.12) (1-119)-HOMO SAPIENS IGHG1*01, G1M17 (CH1 K26>E (149), K119>E (215), K120 (216) (120-217), HINGE 1-6 (218-223)) (120-223)-10-MER BIS(TETRAGLYCYL-SERYL) LINKER (224-233)-V-LAMDDA ANTI-CD3E (MUS MUSCULUS IGLV1*01 (81.2%)-IGLJ1*01 (100%)/HOMO SAPIENS IGLV7-46*01 (80.0%)-IGLJ3*01 (100%)) (9.3.9) (234-342)-2-MER BISERYL LINKER (343-344)-HOMO SAPIENS IGHG1*01, G1M17, G1M1 (CH1 K120 (441) (345-442), HINGE 1-15 (443-457), CH2 L1.3>A (461), L1.2>A (462), P114>G (556) (458-567), CH3 S10>C (581), D12 (583), L14 (585), T22>W (593) (568-672), CHS (673-674)) (345-674)), (222-219')-DISULFIDE WITH KAPPA LIGHT CHAIN HUMANIZED ANTI-MS4A1 (1'-219') (HUMANIZED V-KAPPA (HOMO SAPIENS IGKV2-28*01 (87.0%)-IGKJ4*01 (100%)) (11.3.9) (1'-112')-HOMO SAPIENS IGKC*01 (98.1%), E12>R (128), Q13>K (129), KM3 A45.1 (158), V101 (196) (113'-219'))(447-232''')-DISULFIDE WITH VH-C-KAPPA LIGHT CHAIN HUMANIZED ANTI-CD3E (1'''-232''') (HUMANIZED VH (HOMO SAPIENS IGHV3-23*03 (87.0%)-IGKJ6*01 (90.9%)) (8.10.16) (1'''-125''')-HOMO SAPIENS IGKC*01 (99.1%), T1.3>S (127), KM3 A45.1 (171), V101 (209) (126'''-232''')), GAMMA1 HEAVY CHAIN HUMANIZED ANTI-MS4A1 (1''-449'') (HUMANIZED VH (HOMO SAPIENS IGHV1-69*02 (84.7%)-(IGHD)-IGHJ4*01 (100%)) (8.8.12) (1''-119'')-HOMO SAPIENS IGHG1*01, G1M17,1 (CH1 K26>E (149), K119>E (215), K120 (216) (120''-217''), HINGE 1-15 (218''-232''), CH2 L1.3>A (236), L1.2>A (237), P114>G (331) (233''-342''), CH3 Y5>C (351), D12 (358), L14 (360), T22>S (368), L24>A (370), Y86>V (409) (343''-447''), CHS (448''-449'')) (120''-449'')), (222''-219'''')-DISULFIDE WITH KAPPA LIGHT CHAIN HUMANIZED ANTI-MS4A1 (1''''-219'''') (HUMANIZED V-KAPPA (HOMO SAPIENS IGKV2-28*01 (87.0%)-IGKJ4*01 (100%)) (11.3.9) (1''''-112'''')-HOMO SAPIENS IGKC*01 (98.1%), E12>R (128), Q13>K (129), KM3 A45.1 (158), V101 (196) (113''''-219''''))DIMER (453-228'':456-231'':581-351'')-TRISDISULFIDE
Development code
RG-6026, RG6026, RO-7082859
Sources (6)

Sources

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

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