Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Phase 2 Study of Epcoritamab-R-GemOx With Consolidative ASCT and Additional Epcoritamab in Relapsed/Refractory Transplant-Eligible DLBCL
3 other identifiers
interventional
43
1 country
3
Brief Summary
This phase II trial tests how well epcoritamab in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) works as treatment given after the cancer has not responded to other treatments (salvage therapy) before autologous stem cell transplant in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Epcoritamab is a so-called bispecific antibody, a molecule that can bind simultaneously to two different receptors (proteins present on the cell surface). Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD3 is expressed on T cells, which are important cells of the immune system that help the body fight cancers and infections. CD20 is expressed on the surface of DLBCL cells. By simultaneous binding to CD3 and CD20, epcoritamab brings T cells and DLBCL cells close together and activates the T cells to kill the lymphoma cells. Rituximab is a so-called monoclonal antibody, a molecule that binds to a single receptor. Like epcoritamab, rituximab binds to CD20. After binding to CD20, rituximab activates the immune system to kill the lymphoma cell through several different mechanisms. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Giving epcoritamab-R-GemOx as therapy before an autologous stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2026
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2026
CompletedFirst Posted
Study publicly available on registry
January 26, 2026
CompletedStudy Start
First participant enrolled
April 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 15, 2029
April 24, 2026
April 1, 2026
3.5 years
January 22, 2026
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Complete response (CR)
Defined as achieving a best response of CR during/after epcoritamab + rituximab, gemcitabine and oxaliplatin (R-GemOx) salvage therapy (prior to autologous stem cell transplantation \[ASCT\] or any non-protocol anti-lymphoma therapy) in a response-evaluable participant. Will be estimated by the binomial proportion along with the 95% exact binomial confidence interval
Up to 2 years
Secondary Outcomes (7)
Overall response
Up to 2 years
Ability to proceed to ASCT
Up to 2 years
Progression-free survival
From start of protocol treatment to time of disease relapse/progression or death due to any cause, whichever occurs earlier, assessed up to 2 years
Duration of response
From the time of first achieving CR/PR during/after epcoritamab + R-GemOx salvage therapy to time of disease relapse/progression or death due to any cause, whichever occurs earlier, assessed up to 2 yrs
Overall survival
Time in a participant from start of protocol treatment to time of death due to any cause, assessed up to 2 years
- +2 more secondary outcomes
Study Arms (1)
Treatment (Epcoritamab-R-GemOx)
EXPERIMENTALSALVAGE THERAPY: Patients receive epcoritamab SC on day 8 of cycle 1 and days 1 and 8 of subsequent cycles and R-GemOx on day 1 of each cycle. Cycles repeat every 14 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or PR after cycle 3 may receive one additional cycle at the treating physician's discretion. Patients with CR or PR after completion of Salvage Therapy who are unable to proceed to ASCT may receive Consolidation Therapy as below. ASCT: Patients undergo ASCT. CONSOLIDATION: Patients receive epcoritamab SC on days 1, 8, and 15 of cycle 1 and on days 1 and 15 of subsequent cycles. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT throughout the study. Patients also undergo bone marrow biopsy and/or aspiration as clinically indicated and may undergo tissue biopsy on study.
Interventions
Undergo ASCT
Undergo tissue biopsy
Undergo blood sample collection
Undergo bone marrow biopsy
Undergo CT
Given SC
Given gemcitabine
Given oxaliplatin
Undergo PET
Given rituximab
Eligibility Criteria
You may qualify if:
- Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with study principal investigator (PI) approval
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Histologically confirmed diagnosis of DLBCL, not-otherwise specified (NOS), transformation of indolent B-cell lymphoma, High grade B-cell lymphoma (HGBCL), NOS, primary mediastinal large B-cell lymphoma (PMBCL)
- Biopsy-proven relapsed or refractory disease after 1 prior line of chemoimmunotherapy and:
- CAR-naïve patients (Cohort 1)
- If primary refractory, or relapsed within 12 months and are ineligible for or are unwilling to undergo CD19-directed CAR-T cell therapy
- If relapsed beyond 12 months
- CAR-experienced patients (Cohort 2)
- If relapsed or refractory to CD19-directed CAR T cell therapy
- Measurable disease on computed tomography (CT) scan, defined as a nodal site greater than 1.5 cm in the longest axis or an extranodal site greater than 1.0 cm in the longest axis AND baseline fluorodeoxyglucose-positron emission tomography (FDG-PET) must demonstrate positive lesion compatible with CT defined anatomical tumor sites
- Considered eligible for high-dose chemotherapy followed by ASCT
- +47 more criteria
You may not qualify if:
- Autologous or allogeneic stem cell transplant within 1 year prior to day 1 of study therapy
- Chemotherapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of study therapy other than a single cycle of R-GemOx
- Has received or plans to receive radiotherapy except for palliative radiation to non-target lesions or major surgery within 4 weeks prior day 1 of study therapy
- Prior solid organ transplantation
- Vaccination with live vaccines within 4 weeks of the first dose of study drug or is expected to need any live vaccination during study participation including at least 3 months following the last dose of study treatment.
- COVID-19 non-replicating adenoviral vaccines are permitted with a minimum period of 3 days between the vaccine and a dose of study treatment
- Active medication use known to decrease T-cell numbers or activity or other concurrent immunosuppressive medication within 5 half-lives or 28 days, whichever is longer, prior to randomization except for up to 20 mg prednisone daily or equivalent
- Known active central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement
- Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia, or New York Heart Association (NYHA) heart failure class III-IV, or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months of screening
- Clinically significant liver disease, including active hepatitis, current alcohol abuse, or cirrhosis
- History of severe allergic or anaphylactic reactions to anti CD20 monoclonal or bi-specific antibody therapy, or known significant allergy or intolerance to any component or excipient constituents of the study treatment (and their excipients) and/or other products in the same class
- Clinically significant uncontrolled illness
- Active uncontrolled infection requiring systemic antibiotics
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) within 2 weeks prior to first dose of study treatment
- Current seizure disorder requiring therapy
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
City of Hope Medical Center
Duarte, California, 91010, United States
City of Hope Atlanta Cancer Center
Newnan, Georgia, 30265, United States
City of Hope at Chicago
Zion, Illinois, 60099, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey Shouse
City of Hope Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2026
First Posted
January 26, 2026
Study Start
April 15, 2026
Primary Completion (Estimated)
October 15, 2029
Study Completion (Estimated)
October 15, 2029
Last Updated
April 24, 2026
Record last verified: 2026-04