Actively Recruiting
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
Led by City of Hope Medical Center · Updated on 2026-04-24
43
Participants Needed
3
Research Sites
182 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide documented informed consent
- Agree to use archival tissue from tumor biopsies or obtain study approval if unavailable
- Age 18 years or older
- ECOG performance status of 0 to 2
- Diagnosed with diffuse large B-cell lymphoma (DLBCL) or related lymphoma types
- Disease relapsed or refractory after one prior chemoimmunotherapy
- CAR-naive or CAR-experienced as defined in study criteria
- Measurable disease on CT scan and positive PET scan
- Eligible for high-dose chemotherapy followed by autologous stem cell transplant
- Fully recovered from prior cancer therapy toxic effects (except hair loss)
- Positive for CD20 protein
- Adequate blood counts and organ function as specified
- Negative or controlled HIV, hepatitis B or C infection
- Women of childbearing potential must have a negative pregnancy test
- Agree to use effective birth control or abstain during and after treatment
- Meet additional lab and health criteria for consolidation therapy if applicable
You will not qualify if you...
- Stem cell transplant within 1 year before study
- Recent chemotherapy, immunotherapy, or radiotherapy as specified
- Prior solid organ transplant
- Recent live vaccinations or expected live vaccination during study
- Use of immunosuppressive drugs except low-dose steroids
- Active central nervous system lymphoma involvement
- Significant cardiovascular disease or recent heart events
- Significant liver disease or alcohol abuse
- Known severe allergic reactions to study treatments
- Active uncontrolled infection or recent serious infections
- Seizure disorder requiring treatment
- Peripheral neuropathy grade greater than 1 except lymphoma related
- Other active malignancy interfering with study
- Recent major surgery (within 4 weeks) except diagnosis-related
- Active hepatitis B or C infection unless controlled
- Active HIV infection unless controlled with therapy
- Active cytomegalovirus disease
- Active or recent tuberculosis
- History or current progressive multifocal leukoencephalopathy
- Unresolved toxicities from prior cancer therapy except hair loss
- Pregnant or breastfeeding females
- Unable to tolerate subcutaneous injections
- Any other condition the investigator deems unsafe or incompatible with study participation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope Atlanta Cancer Center
Newnan, Georgia, United States, 30265
Not Yet Recruiting
3
City of Hope at Chicago
Zion, Illinois, United States, 60099
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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