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Axicabtagene ciloleucel

  • Gene therapy
  • 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 Axicabtagene ciloleucel does in the body

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

From the FDA-approved label: YESCARTA, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells.

Why people take it. YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

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 structurallydiverse.

    FDA substance registry · U2I8T43Y7R · read 2026-08-29

  • It is recorded as coming from HOMO SAPIENS WHOLE. The part recorded is blood.

    FDA substance registry · U2I8T43Y7R · 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 156 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.

Proportion of Participants in Complete Response (CR) at Month 6

The study did not show it

Who was studied
NCT07479797
How many people
550
Study design
Phase 3
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

Event free survival

The study did not show it

Who was studied
NCT07188558
How many people
400
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

Progression free survival (PFS)

The study did not show it

Who was studied
NCT05633615
How many people
396
Study design
Phase 2
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

Event Free Survival (EFS) Per Blinded Central Assessment

The study did not show it

Who was studied
NCT03391466
How many people
359
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

Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)

The study did not show it

Who was studied
NCT02348216
How many people
307
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) from date of IMP infusion (if applicable)

The study did not show it

Who was studied
NCT05641428
How many people
300
Study design
Phase 2
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 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.

  • YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

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 YESCARTA have not been established in pediatric patients.”

    US prescribing information · 9b70606e-b99c-4272-a0f1-b5523cce0c59 · read 2026-08-30

  • On older people, the label states: “Of the 422 patients with NHL who received YESCARTA in clinical trials, 127 patients (30%) were 65 years of age and older.”

    US prescribing information · 9b70606e-b99c-4272-a0f1-b5523cce0c59 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary There are no available data with YESCARTA use in pregnant women.”

    US prescribing information · 9b70606e-b99c-4272-a0f1-b5523cce0c59 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of YESCARTA in human milk, the effect on the breastfed infant, and the effects on milk production.”

    US prescribing information · 9b70606e-b99c-4272-a0f1-b5523cce0c59 · 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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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, S4, S6, S7.

No source is stored against this line.

What is in the pack

Sold as suspension, 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.

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

  • 1 product lists this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.

    FDA National Drug Code directory · 71287-119 · read 2026-08-29

  • They are sold as suspension, taken intravenous.

    FDA National Drug Code directory · 71287-119 · read 2026-08-29

  • The regulator's established pharmacologic class for it is autologous, cd19 receptor interactions [moa] and cd19-directed chimeric antigen receptor [epc].

    FDA National Drug Code directory · 71287-119 · 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 · 9b70606e-b99c-4272-a0f1-b5523cce0c59 · read 2026-08-29

  • Those labels are classed as cellular therapy.

    US prescribing information · 9b70606e-b99c-4272-a0f1-b5523cce0c59 · read 2026-08-29

  • YESCARTA is intravenous at 3 DOSAGE FORMS AND STRENGTHS YESCARTA is available as a cell suspension for infusion., recorded as fda label in effect 2026-08-06 in the United States.

    US prescribing information · 9b70606e-b99c-4272-a0f1-b5523cce0c59 · 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 Axicabtagene ciloleucel 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)
U2I8T43Y7R
RxNorm concept
1987402

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, S4, S6, S7.

  • 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 20171018.

    FDA National Drug Code directory · 71287-119 · 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

9 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.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (8)

On the Axicabtagene ciloleucel label: indicated for what?

"YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. ( 1.1 ) Adult patients with relapsed or…": indications and usage on Axicabtagene ciloleucel's label. DailyMed label · 9b70606e-b99c-4272-a0f1-b5523cce0c59 · 2026-08-06

46 registered trials of Axicabtagene ciloleucel — at which phases?

Registered studies posting no result
30 of 46

46 registered studies of Axicabtagene ciloleucel: 26 phase2, 12 phase1, 5 phase3, 4 na or unstated, 2 phase4, 1 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01

40 with a PubMed record

Show the evidence
  • phase2
    26
  • phase1
    12
  • phase3
    5
  • na or unstated
    4
  • phase4
    2
  • na
    1
9 more recorded rows
  • recruiting
    15
  • completed
    14
  • active not recruiting
    6
  • terminated
    4
  • not yet recruiting
    3
  • approved for marketing
    1
  • available
    1
  • enrolling by invitation
    1
  • suspended
    1

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

5 of Axicabtagene ciloleucel's trials stopped: safety, accrual/recruitment, other?

safety (1), accrual/recruitment (2) and other (2): Axicabtagene ciloleucel's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Development program terminated"; 5 of 46 registered studies

Show the evidence

Trial

  • NCT03704298
    terminated; "Development program terminated"
  • NCT04205838
    terminated; "slow accrual"
  • NCT04314843
    terminated; "Development program terminated and the decision was not due to any safety concerns."
  • NCT04855253
    suspended; "Accrual met"
  • NCT06912529
    terminated; "Funder of the study terminated contract"

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

Which running trial of Axicabtagene ciloleucel could settle lifespan?

NCT05757219 measures Progression Free Survival (PFS), reading out 2027-01.

5 open trials; n 27; "Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy"

Show the evidence

Trial

  • NCT05757219
    "Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy"; n 27; "Progression Free Survival (PFS)"; 2027-01
  • NCT05633615
    "Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma"; n 396; "Progression free survival (PFS)"; 2030-06-30
  • NCT05371093
    "Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma"; n 231; "Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification"; 2030-10
  • NCT05605899
    "Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma"; n 300; "Event-free Survival (EFS) by Blinded Central Assessment"; 2031-03
  • NCT07188558
    "A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy"; n 400; "Event free survival"; 2032-01

Which one trial of Axicabtagene ciloleucel posted no result?

Posted no result
1 of 1 completed trials
Registrations
NCT05349201
Completion dates
oldest 2021-05-28
Show the evidence
  • Trial NCT05349201
    2021-05-28

At the median, Axicabtagene ciloleucel's trials enrolled 31 people — anything larger?

Median enrolment
31
Largest enrolment
1000
Registered trials counted
44

What do 3471 spontaneous reports say about Axicabtagene ciloleucel — 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.

Axicabtagene ciloleucel appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3471 reaction mentions were counted: cytokine release syndrome 1319; neurotoxicity 642; pyrexia 379; immune effector cell-associated neurotoxicity syndrome 302. FAERS via Open Targets · CHEMBL3989989 · 2026-06-24

Show the evidence
  • cytokine release syndrome
    1319
  • neurotoxicity
    642
  • pyrexia
    379
  • immune effector cell-associated neurotoxicity syndrome
    302
  • hypotension
    165
  • encephalopathy
    157
4 more recorded rows
  • confusional state
    150
  • neutropenia
    132
  • aphasia
    130
  • tachycardia
    95

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

Which 10 reactions does Axicabtagene ciloleucel's label not list?

aphasia, confusional state and cytokine release syndrome and 7 more reported for Axicabtagene ciloleucel, absent from its label. FAERS via Open Targets · CHEMBL3989989 · 2026-06-24

2 label terms; 10 reported and unlisted; 9b70606e-b99c-4272-a0f1-b5523cce0c59

Show the evidence
  • aphasia
    count not stated
  • confusional state
    count not stated
  • cytokine release syndrome
    count not stated
  • encephalopathy
    count not stated
  • hypotension
    count not stated
  • immune effector cell-associated neurotoxicity syndrome
    count not stated
4 more recorded rows
  • neurotoxicity
    count not stated
  • neutropenia
    count not stated
  • pyrexia
    count not stated
  • tachycardia
    count not stated

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL3989989
RxCUI
1987398
Development code
KTE-C19
Also called
Axicabtagen ciloleucel, Yescarta, axi-cel, AUTOLOGOUS T CELLS TRANSDUCED WITH RETROVIRAL VECTOR ENCODING AN ANTI-CD-19 CD28/CD3-ZETA CHIMERIC ANTIGEN RECEPTOR, AXICABTAGENE CILOLEUCEL [USAN], Axicabtagene ciloleucel [WHO-DD], Cells are derived from isolated blood of the patient and are transduced with non-replicative retroviral vector encoding the FMC63 anti-CD19 single chain variable fragment (scFv) CD28/CD3zeta chimeric antigen receptor (FMC63-28Z CAR). Cells exhibit anti-tumoral activity in patients with CD19-expressing B cell malignancies, axicabtagene ciloleucel [INN]
Sources (5)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · 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

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 5 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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