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Lymphoma, Non-HodgkinPhase 2NCT06458439

Epcoritamab-CAR T Cells for Large B-cell Lymphomas

A Phase 2 study testing Epcoritamab in people with Lymphoma, Non-Hodgkin and Relapsed Diffuse Large B Cell Lymphoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study investigates the feasibility and efficacy of epcoritamab treatment before CAR T cells. This study also investigates if, when patients have residual lymphoma after CAR T cells, epcoritamab can help to effectively treat that lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Epcoritamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
24 Sep 2024to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 years
  • Subject must be able and willing to provide informed consent. In the case where the patient is incapacitated or not otherwise capable, a legally authorized representative (or decision maker when there is not an advanced directive in place) must be willing to provide informed consent on behalf of the patient.
  • Able to comply with the study protocol, in the investigator's judgment
  • ECOG PS of 0 - 2
  • Pathology report confirming eligible diagnosis
  • Documented CD20+ tumor cells on most recent biopsy
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  • Patients will have failed to respond to frontline standard of care therapy containing an anthracycline and anti-CD20 antibody
  • Patients will be eligible and consent to be treated with a "commercially available" anti-CD19, 4-1BB, CD3zeta CAR-T cell therapy or anti-CD19, CD28, CD3zeta CAR T cell therapy (for example, tisagenlecleucel, lisocabtagene maraleucel, or axicabtagene maraleucel)
  • Patients must have a PET/CT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesions or ≥ 1cm for extra-nodal lesions in largest dimension by low-dose computerized tomography [CT] scan with FDG-uptake ≥ liver)
  • Adequate laboratory studies
  • Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator
  • Ability and willingness to take proper contraceptive precautions

Who cannot join

  • Inability or unwillingness of the patient or legally authorized representative (or decision-maker when there is not an advanced directive in place) to provide informed consent.
  • Prior solid organ transplantation
  • Primary central nervous system (CNS) lymphoma or active secondary CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) or, if clinically indicated, by lumbar puncture.
  • History of autoimmune disease or other diseases resulting in permanent immunosuppression or requiring chronic immunosuppressive therapy (see Exclusion Criteria 5a), with the following exceptions:
  • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone
  • Patients with a history of lymphoma-related immune thrombocytopenic purpura or autoimmune hemolytic anemia in remission may be eligible for this study if approved by the Regulatory Sponsor and Principal Investigator
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  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
  • Rash must cover < 10% of body surface area ii. Disease is well controlled at baseline and requires only low-potency topical corticosteroid iii. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or corticosteroids (> 20 mg/day prednisone or equivalent for > 2 weeks) within the previous 3 months d. rheumatoid arthritis or similar autoimmune/rheumatic conditions
  • Systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents). However, the following are permitted:
  • If receiving glucocorticoid treatment at screening, must be a maximum daily dose of prednisone 10 mg (or equivalent) and a total of no more than 140 mg over the last 14 days prior to the first dose of epcoritamab, unless for disease control.
  • Patients who received a single dose of a systemic immunosuppressant medications (e.g., single dose of dexamethasone for nausea or B symptoms) may be enrolled
  • The use of inhaled corticosteroids is permitted
  • The use of mineralocorticoids for management of orthostatic hypotension is permitted
  • The use of physiologic doses of corticosteroids (< 20 mg/day of prednisone or equivalent) for uses such as management of adrenal insufficiency is permitted
  • Known past or current malignancy, other than inclusion diagnoses, except for:
  • Cervical carcinoma of Stage 1B or less.
  • Adequately resected, non-metastatic basal cell or squamous cell skin carcinoma.
  • Non-invasive, superficial bladder cancer.
  • Prostate cancer with a current PSA level <0.1 ng/mL.
  • Patients with a malignancy that has been treated with curative intent will also be enrolled if that malignancy is in remission prior to first dose of epcoritamab
  • Known clinically significant cardiovascular disease
  • Patients with the following active infection(s) could have increased risks for toxicity if treated with bispecific antibody therapy, thus patient will be excluded if:
  • Positive serologic or PCR test results for acute or chronic HBV infection. Patients whose HBV infection status cannot be determined by serologic test results (www.cdc.gov/hepatitis/hbv/pdfs/serologicchartv8.pdf) must be negative for HBV by PCR to be eligible for study participation. Patients with a history of hepatitis B who are negative for HBV by PCR, will not be excluded but will be placed on suppressive antiviral therapy
  • Acute or chronic HCV infection. Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation. Patients with a history of hepatitis C who have been adequately treated (negative PCR) will not be excluded.
  • Positive serologic or RT-PCR test results for HIV infection.
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major documented infection requiring treatment with IV antibiotics or hospitalization within 2 weeks of enrollment. Empiric or prophylactic antibiotics administered during neutropenia or neutropenic fever without microbiologic evidence of infection do not exclude patients.
  • Clinically significant pulmonary disease (e.g., bronchospasm and/or obstructive pulmonary disease) that requires chronic oxygen or corticosteroid use > 20 mg mg/day prednisone or equivalent
  • Uncontrolled seizure disorder
  • Exposure to live or live attenuated vaccine within 4 weeks prior to signing ICF
  • Pregnancy or breast feeding
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brittany Koch contact

215-776-5548

Brittany.Koch@pennmedicine.upenn.edu

Kaitlin Kennard contact

Kaitlin.Kennard@pennmedicine.upenn.edu

United States1 site, 1 recruiting

  • Abramson Cancer Center at the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Brittany Koch, 215-776-5548, Brittany.Koch@pennmedicine.upenn.edu

    Kaitlin Kennard, Kaitlin.Kennard@pennmedicine.upenn.edu

    Recruiting

Other trials in United States

About this study

Official title: Phase IIa Trial to Evaluate Epcoritamab Administered Before and After CAR-T Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphomas

This study investigates the feasibility and efficacy of epcoritamab treatment before CAR T cells. This study also investigates if, when patients have residual lymphoma after CAR T cells, epcoritamab can help to effectively treat that lymphoma.

Being tested
Epcoritamab
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpcoritamabDrug

    Also called GEN3013, DuoBody -CD3xCD20

    • C1D1: fixed priming dose of 0.16 mg subcutaneous injection
    • C1D8: fixed intermediate dose of 0.8 mg subcutaneous injection
    • C1D15 onward: fixed full dose of 48 mg subcutaneous injection
Study groups in NCT06458439
Study groupRoleWhat they receive
EpcoritamabExperimentalStudy participants will bridging epcoritamab on Cycles 1-3, Days 1, 8, 15, and 22 (once weekly).
Receives: Drug: Epcoritamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of CAR T cell infusion among subjects who receive epcoritamab and undergo leukapheresis

    Whether participants receive CAR T-cell infusion (yes/no)

    Measured: Start of epcoritamab to CAR T-cell infusion

Secondary outcomes (8)

  1. Incidence and severity of AEs, SAEs from epcoritamab until CAR T cell infusion

    Assessment of toxicity via incidence and severity of AEs and SAEs via CTCAE v5

    Measured: Day 1 of epcoritamab until CAR T cell infusion

  2. Overall Response Rate after 2 cycles of Epcoritamab

    Percentage of subjects who receive epcoritamab and have a CR or PR by Lugano 2014 criteria prior to CAR T-cells

    Measured: Day 1 of epcoritamab to completion of 2 cycles of epcoritamab

  3. Incidence and severity of AEs, SAEs after CAR T cell infusion through day 28 visit after CAR T-cell infusion

    Assessment of toxicity via incidence and severity of AEs and SAEs via CTCAE v5

    Measured: CAR T cell infusion through day 28 visit after CAR T-cells

  4. Day 28 visit response rates post CAR T cell infusion

    Overall response rate as well as complete response rate after CAR T-cells

    Measured: Day 28 visit after CAR T cell infusion

  5. Progression-free survival, duration of response, and overall survival for those subjects achieving complete response at Day 28 visit post CAR T cell infusion

    Duration of response from day 28 visit after CAR T-cells, progression-free survival and overall survival from CAR T-cell infusion

    Measured: CAR T cell infusion until last follow-up or death

  6. Incidence and severity of AEs, SAEs from day 28 visit after CAR T-cell infusion until epcoritamab discontinuation

    Assessment of toxicity via incidence and severity of AEs and SAEs via CTCAE v5

    Measured: Day 28 visit after CAR T-cell infusion until epcoritamab discontinuation up to 12 cycles of epcoritamab

  7. Responses at 3 and 6 months after CAR T-cell infusion for subjects who receive epcoritamab after CAR T-cells

    Best overall response rate, overall response rate, and complete response rate at 3 and 6 months after CAR T cell infusion for subjects who receive epcoritamab after CAR T-cells

    Measured: 3 and 6 months after CAR T-cell infusion

  8. Duration of response, progression-free survival and overall survival from time of CAR T-cell infusion for subjects who receive post CAR T-cell epcoritamab infusions

    Duration of response from first response after CAR T-cell infusion, progression-free survival and overall survival from CAR T-cell infusion

    Measured: From CAR T-cell infusion until date of last follow-up or date of death due to any cause, whichever comes first, assessed up to 5 years from last dose of epcoritamab

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start24 Sep 2024
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06458439
Sponsor's protocol ID
UPCC 03424
Other IDs
IRB#855865
Status last verified
May 2026
First submitted
7 Jun 2024
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epcoritamab in people with Lymphoma, Non-Hodgkin and Relapsed Diffuse Large B Cell Lymphoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brittany Koch (215-776-5548, Brittany.Koch@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of CAR T cell infusion among subjects who receive epcoritamab and undergo leukapheresis (time frame: Start of epcoritamab to CAR T-cell infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06458439.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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