Epcoritamab for Relapsed or Refractory Large B-cell Lymphoma
This study is testing a new approach for people with large B-cell lymphoma (LBCL) that has come back or hasn't responded to previous treatments. It combines epcoritamab, a drug that helps your immune system fight cancer, with standard chemotherapy and an autologous hematopoietic cell transplant (autoHCT). Epcoritamab works by targeting two proteins: CD3 on your T-cells (a type of white blood cell) and CD20 on lymphoma cells. Researchers want to see how many people have a complete response (meaning the cancer is no longer detectable) after this treatment. The study plans to enroll 25 participants who are 18 years or older and have specific types of relapsed or refractory LBCL.
- Study design
- This is an interventional study with an unspecified phase, planning to enroll 25 participants. It combines epcoritamab with standard chemotherapy and autologous hematopoietic cell transplant.
- What's involved
- Participants will receive epcoritamab injections and standard chemotherapy before and after an autologous hematopoietic cell transplant. Treatment cycles repeat every 28 days for varying durations.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 2 years after their autologous hematopoietic cell transplantation to measure their complete response rate.
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NCT06905509
Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of California, DavisInvestigator-initiated
~25 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Autologous Hematopoietic Stem Cell TransplantationCarboplatinCytarabineDexamethasoneEpcoritamabEtoposide Phosphate
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response rate (CRR)
Measured over From first dose up to 2 years post-autologous hematopoietic cell transplantation (autoHCT) therapy
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Joseph M Tuscano · STUDY_CHAIR · University of California, Davis
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must have histologically or cytologically confirmed R/R LBCL
Can include diffuse large B-cell lymphoma (DLBCL) (not otherwise specified \[NOS\] or with concurrent MYC and BCL2 rearrangements), high-grade B-cell lymphoma (HGBCL) (NOS or with MYC and BCL2 or BCL6 rearrangements) and transformed follicular lymphoma (FL) and nodal marginal zone lymphoma (MZL)
Histological confirmed CD20+ relapsed/ refractory large cell lymphoma
Must have had relapsed or refractory disease following standard frontline chemotherapy. Refractory disease is defined as large cell lymphoma not achieving complete remission, progressing, or relapsing within 6 months after first-line chemotherapy based on PET/CT per the Lugano criteria. Relapsed disease is defined as disease that recurs beyond 6 months after completion of initial chemotherapy based on PET/CT per the Lugano criteria
Have received 1 or more prior lines of systemic therapy for the treatment of large cell lymphoma. NOTE: Prior radiation therapy or systemic corticosteroids will not be considered a line of therapy
Candidate for platinum-containing chemotherapy (RICE, RDHAP/X, or R-Gem/Ox) pre-autologous hematopoietic cell transplantation (autoHCT) followed by autoHCT as per institutional guidelines
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Measurable disease via diagnostic quality CT or PET/CT with at least 1 node having the longest diameter (LDi) greater than (\>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi \> 1 cm (per the Lugano criteria 2014)
Aged ≥ 18 at the time of consent
Creatinine clearance (CrCl) ≥ 45 mL/min (Cockcroft-Gault)
Serum alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN)
Serum aspartate aminotransferase (AST) ≤ 3 x ULN
Bilirubin ≤ 1.5 x ULN unless due to Gilbert's syndrome or controlled autoimmune hemolytic anemia (not requiring immunosuppressive other than ≤ 20 mg of prednisolone daily)
Note: Patients with Gilbert's syndrome may be included if total bilirubin is ≤ 3 x ULN and direct bilirubin is ≤ 1.5 x ULN
Hemoglobin ≥ 8.0 g/dL
Note: Blood transfusion may be administered during Screening to meet this requirement only if anemia is due to marrow involvement of non-Hodgkin lymphoma (NHL)
Absolute neutrophil count ≥ 1000/uL
Note: Growth factor support is allowed to meet this requirement at Screening only if directly attributable to NHL infiltration of the bone marrow, proven by bone marrow biopsy
Platelet count ≥ 75,000/uL or ≥ 50,000/uL if bone marrow (BM) involvement or splenomegaly
Note: Transfusion may be administered during screening to meet this requirement
prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
Note: If any of the above-mentioned cytopenias are present, there should be no evidence of myelodysplastic syndrome (MDS) or hypoplastic bone marrow
HIV-infected patients on effective anti-retroviral therapy with stable viral load and CD4 count for 1 year prior to enrollment are eligible for this trial. Testing for HIV viral load and antibody at screening is mandatory
Patients with a history of chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load on suppressive therapy, if indicated. Patients with evidence of prior HBV but who are polymerase chain reaction (PCR)-negative are permitted in the trial but should receive prophylactic antiviral therapy. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Patients who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C ribonucleic acid (RNA) levels are undetectable. Testing for HBV and HCV is mandatory at screening
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 12 months after the last dose of epcoritamab
Provision of signed and dated informed consent form
Exclusion
Any adverse event (AE) related to the previous large cell lymphoma therapy which has not recovered to grade ≤ 1 (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\] 5.0) or baseline by cycle 1 day 1 (C1D1), except alopecia and non-clinically significant laboratory abnormalities
Uncontrolled intercurrent illness (including infection)
Known active central nervous system or meningeal (including leptomeningeal) involvement. Patients diagnosed with central nervous system (CNS) disease who achieved and maintained CNS complete response (CR) at the time of relapse are eligible. Lumbar puncture must be done in this case prior to study entry (within 90 days of enrollment) to demonstrate CNS CR status. Tests to investigate CNS involvement are required otherwise only if clinically indicated (i.e. disease suspected on basis of symptoms or other findings)
Receiving any other investigational treatments
Previous treatment with any bispecific T-cell engager with or without chemotherapy
Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab
Concurrent use of other anti-cancer agents or treatments except for certain therapeutics (e.g., prostate, breast hormonal-based therapy) per the treating physician's discretion
Standard agents within 2 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab (excluding anti-CD20 monoclonal antibodies \[mAbs\], which can be administered until first full dose of epcoritamab); or
CAR-T cell therapy within 30 days prior to the first dose of epcoritamab
Palliative radiation is permitted only if on non-target lesions
Motor and sensory neuropathy grade ≥ 2 (CTCAE v.5.0)
Patients with a history of other malignancies, except adequately treated non-melanoma skin cancer, non-invasive superficial bladder cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, localized low grade prostate cancer (up to Gleason score 6), or other solid tumors curatively treated with no evidence of disease for at least 3 years
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at trial enrollment or significant infections within 2 weeks prior to the first dose of epcoritamab
Confirmed history or current autoimmune disease or other diseases requiring permanent immunosuppressive therapy. Low-dose (10 mg/day) prednisolone (or equivalent) for rheumatoid arthritis or similar conditions is allowed
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)
Participant received any prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation
Autoimmune disease or other diseases that require continuous immunosuppressive therapy (except for prednisone doses of less than or equal to 10 mg, which is allowed)
Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia (requiring \> 20 mg of prednisolone daily) or other concurrent uncontrolled medical conditions
Clinically significant cardiac disease including but not limited to:
Unstable or uncontrolled disease/condition related to or affecting cardiac function, e.g., unstable angina, congestive heart failure grade III or IV as classified by the New York Heart Association, uncontrolled clinically significant cardiac arrhythmia (CTCAE v 5.0 grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities. Controlled New York Heart Association (NYHA) grade 1 or 2 are eligible
Myocardial infarction, intracranial bleed, or stroke within the past 6 months
Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \> 480 msec. NOTE: This criterion does not apply to participants with a left bundle branch block
In case of any history of cardiovascular disease, a cardiology consult is required within 60 days prior to enrollment
Age ≥ 75 and 2 or more active grade ≥ 2 cardiovascular conditions
Prior treatment with live, attenuated vaccines within 28 days prior to initiation of epcoritamab. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus Calmette-Guerin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Food and Drug Administration (FDA)-approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinations allowed
Immune effector cell encephalopathy (ICE) score of less than 10 at study entry
Suspected allergies, hypersensitivity, or intolerance to epcoritamab or another anti-CD20 mAb or its excipients
Active HBV (DNA PCR-positive). Patients with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy
Active hepatitis C (RNA PCR-positive infection). Patients who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable
Known history of seropositivity for HIV infection
Active cytomegalovirus (CMV) infection (PCR positive)
Pregnant, breastfeeding, or planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab
Plans to donate sperm or conceive a child through intercourse while enrolled in this trial or within 12 months after the last dose of epcoritamab
Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrollment or within the previous 2 weeks prior to the first dose of epcoritamab
Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection. Note: SARS-CoV-2 diagnostic tests should be applied following local requirements/recommendations. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen per criteria
Suspected active or inadequately treated latent tuberculosis
What this trial measures
- Complete response rate (CRR)From first dose up to 2 years post-autologous hematopoietic cell transplantation (autoHCT) therapy
Will be assessed by Lugano 2014. Will be calculated as the number of participants achieving complete response divided by the number of evaluable patients. CRR will be presented alongside the corresponding exact binomial 95% confidence interval.