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Epcoritamab-Bysp

  • Biologic
  • Prescription only
  • 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 Epcoritamab-Bysp does in the body

EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.

Epcoritamab-bysp is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and healthy B-lineage cells. In vitro, epcoritamab-bysp activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells. In nonclinical studies, the combination of epcoritamab-bysp and rituximab resulted in both T-cell mediated cytotoxicity and natural killer (NK) cell mediated antibody-dependent cellular cytotoxicity (ADCC).

Why people take it. EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell 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 · D6OMY2L0WA · 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 174 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.

Formulation

A formulation is the exact made-up form a substance comes in.

A picture of it, and where the picture fails

It is like the difference between a whole bean and instant coffee.

Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.

What people get wrong. Two products with the same name are assumed to behave the same. They often do not.

The specific composition and physical form of a product, including salt, excipients and release profile.

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.

Objective status of complete response (CR)

The study did not show it

Who was studied
NCT06238648
How many people
120
Study design
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Complete response (CR)

The study did not show it

Who was studied
NCT07365306
How many people
43
Study design
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Proportion of participants who complete at least Cycle 3 among 10 participants (Feasibility)

The study did not show it

Who was studied
NCT07662928
How many people
43
Study design
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Incidence of adverse events (AEs)

The study did not show it

Who was studied
NCT06536049
How many people
38
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Best response of complete response (CR) rate

The study did not show it

Who was studied
NCT06723457
How many people
34
Study design
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Minimal residual disease (MRD) negative complete response (CR)

The study did not show it

Who was studied
NCT07218510
How many people
33
Study design
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · 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.

  • Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indo

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 EPKINLY in pediatric patients have not been established.”

    US prescribing information · d7836711-b677-412d-bf2d-0f7c8444103a · read 2026-08-30

  • On older people, the label states: “LBCL In patients with relapsed or refractory LBCL who received EPKINLY in EPCORE NHL-1, 77 (49%) were 65 years of age and older, and 29 (19%) were 75 years of age or older.”

    US prescribing information · d7836711-b677-412d-bf2d-0f7c8444103a · read 2026-08-30

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

    US prescribing information · d7836711-b677-412d-bf2d-0f7c8444103a · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of epcoritamab-bysp in human milk, the effect on the breastfed child, or milk production.”

    US prescribing information · d7836711-b677-412d-bf2d-0f7c8444103a · 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.

A different form was studied

The studied form is not the form on the shelf.

On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.

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)
It was studied for a different goal
The studies measured something else entirely. 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

Prescription only

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No form or route is recorded.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing is recorded about product quality.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

The exact form studied is not recorded.

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 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 · d7836711-b677-412d-bf2d-0f7c8444103a · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · d7836711-b677-412d-bf2d-0f7c8444103a · read 2026-08-29

  • EPKINLY is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS EPKINLY is a clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous injection: Injection: 4 mg/0.8 mL in a single-dose vial Injection: 48 mg/0.8 mL in a single-…, recorded as fda label in effect 2026-06-22 in the United States.

    US prescribing information · d7836711-b677-412d-bf2d-0f7c8444103a · 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.

Names and forms linked to this record

  • Biosimilar of

    Epcoritamab

    Evidence on this page does not automatically apply to this one.

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 Epcoritamab-Bysp 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.

Formulation uncertainty

Several salts, forms or products of Epcoritamab-Bysp are recorded. Results from one form may not transfer to another.

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)
D6OMY2L0WA
RxNorm concept
2637399

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

  • 1 approved application covers products containing this substance. The earliest was BLA761324, approved 20230519 to GENMAB US, INC..

    Drugs@FDA application register · BLA761324 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA761324 · 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 (6)

On the Epcoritamab-Bysp label: indicated for what?

"EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.…": indications and usage on Epcoritamab-Bysp's label. DailyMed label · d7836711-b677-412d-bf2d-0f7c8444103a · 2026-06-22

25 registered trials of Epcoritamab-Bysp — at which phases?

Registered studies posting no result
24 of 25

25 registered studies of Epcoritamab-Bysp: 20 phase2, 9 phase1, 3 phase3. CLINICALTRIALS_SNAPSHOT · 2026-09-01

0 with a PubMed record

Show the evidence
  • phase2
    20
  • phase1
    9
  • phase3
    3
  • recruiting
    10
  • active not recruiting
    8
  • not yet recruiting
    4
2 more recorded rows
  • terminated
    2
  • suspended
    1

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

3 of Epcoritamab-Bysp's trials stopped: safety, futility/efficacy?

safety (2) and futility/efficacy (1): Epcoritamab-Bysp's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Due to strategic evaluation of GEN3009 within context of Genmab's portfolio, decision not based on any safety or regulatory concerns."; 3 of 25 registered studies

Show the evidence

Trial

  • NCT04358458
    terminated; "Due to strategic evaluation of GEN3009 within context of Genmab's portfolio, decision not based on any safety or regulatory concerns."
  • NCT05660967
    terminated; "The study was terminated because sufficient data had been collected to meet the objectives of the development program. No new or unexpected safety findings were identified, and the decision to terminate was not related to participant…"
  • NCT06575686
    suspended; "Pending Interim Analysis"

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

Epcoritamab-Bysp's half-life is 22 days — which schedules were studied?

22 days, the half-life Epcoritamab-Bysp's label states: "Elimination The half-life of full dose epcoritamab-bysp (48 mg) was approximately 22 days (58%) at the end of Cycle 3, with apparent total clearance of approximately 0.53 L/day (40%) after the end of Cycle 3." DailyMed label · d7836711-b677-412d-bf2d-0f7c8444103a · 2026-06-22

Show the evidence
  • half life pharmacokinetics
    22 days; Elimination The half-life of full dose epcoritamab-bysp (48 mg) was approximately 22 days (58%) at the end of Cycle 3, with apparent total clearance of approximately 0.53 L/day (40%) after the end of Cycle 3.
  • metabolism pharmacokinetics
    Metabolism Epcoritamab-bysp is expected to be metabolized into small peptides by catabolic pathways.

recorded 2026-06-22 · last checked 2026-09-04

Which running trial of Epcoritamab-Bysp could settle lifespan?

NCT04628494 measures Overall Survival (OS), reading out 2028-04.

3 open trials; n 483; "A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)"

Show the evidence

Trial

  • NCT04628494
    "A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)"; n 483; "Overall Survival (OS)"; 2028-04
  • NCT07226752
    "A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China"; n 72; "Overall Survival (OS)"; 2028-06-14
  • NCT07714421
    "Epcoritamab and Pola-R-mini-CHP for the Treatment of Diffuse Large B Cell Lymphoma in Elderly or Unfit Patients"; n 20; "Progression free survival"; 2031-10-08

At the median, Epcoritamab-Bysp's trials enrolled 43 people — anything larger?

Median enrolment
43
Largest enrolment
1095
Registered trials counted
25
Where it is registered
Identifiers, relations and other names

The exact record

CAS number
2134641-34-0
RxCUI
2637399

Relations

Trade name
Epkinly
Also called
EPCORITAMAB, EPCORITAMAB [USAN], Epcoritamab [MI], Epcoritamab [WHO-DD], Epcoritamab bysp [WHO-DD], Immunoglobulin G1 [234-phenylalanine, 235-glutamic acid, 265-alanine, 405-leucine], anti-(human CD3 antigen) (human-Mus musculus monoclonal IgG1-huCACAO-FEAL γ1-chain), disulfide with human-Mus musculus monoclonal IgG1-huCACAO-FEAL λ-chain, (234→231'),(237→234')-bis(disulfide) with immunoglobulin G1 [234-phenylalanine, 235-glutamic acid, 265-alanine, 409-arginine] anti-(human CD20 antigen) (human monoclonal IgG1-7D8-FEAR γ1-chain) disulfide with human monoclonal IgG1-7D8-FEAR κ-chain, Immunoglobulin G1-lambda/kappa, anti-[Homo sapiens CD3E (CD3 epsilon)] and anti-[Homo sapiens MS4A1 (membrane-spanning 4-domains subfamily A member 1, CD20)], monoclonal bispecific antibody; gamma1 heavy chain chimeric anti-CD3E (1-454) [VH (Mus musculus IGHV10-1*02 (93.9%) -(IGHD) -IGHJ3*01 (93.3%)/Homo sapiens IGHV3-72*01 (81.0%) -(IGHD) -IGHJ6*01 (67.0%)) [8.10.16] (1-125) -Homo sapiens IGHG1*03 G1m3, nG1m1 (CH1 R120 (222) (126-223), hinge 1-15 (224-238), CH2 L1.3>F (242), L1.2>E (243), D27>A (273) (239-348), CH3 E12 (364), M14(366), F85.1>L (413) (349-453), CHS K2>del (454)) (126-454)], (228-214')-disulfide with lambda light chain chimeric (1'-215') [V-LAMBDA (Mus musculus IGLV1*01 (83.3%) -IGLJ1*01 (100%)/Homo sapiens IGLV8-61*01 (70.8%) - IGLJ3*02 (100%)) [9.3.9] (1'-109') -Homo sapiens IGLC2*01 (100%) (110'-215')]; gamma1 heavy chain Homo sapiens anti-MS4A1 (1''-451'') [VH (Homo sapiens IGHV3-9*01 (96.0%) -(IGHD) -IGHJ6*01 (100%)) [8.8.15] (1''-122'') -Homo sapiens IGHG1*03 G1m3, G1m1 (CH1 R120 (219) (123-220), hinge 1-15 (221-235), CH2 L1.3>F (239), L1.2>E (240), D27>A (270) (236-345), CH3 E12 (361), M14 (363), K88>R (414) (346-450), CHS K2>del (451)) (123''-451'')], (225''-214''')-disulfide with kappa light chain Homo sapiens (1'''-214''') [V-KAPPA (Homo sapiens IGKV3-11*01 (100%) -IGKJ5*01 (100%)) [6.3.9] (1'''-107''') -Homo sapiens IGKC*01 (100%), Km3 A45.1 (153), V101 (191) (108'''-214''')]; dimer (234-231'':237-234'')-bisdisulfide, produced in Chinese Hamster Ovary (CHO)-S cell line, glycoform alfa, epcoritamab [INN]
Development code
GEN-3013
Sources (4)

Sources

ClinicalTrials.gov — US Government work · 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: 3 required field(s) not terminal: Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 4 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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