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NCT07365306 · ClinicalTrials.gov registry record · Phase 2
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, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT07365306: Recruiting Phase 2 study, sponsored by City of Hope Medical Center.
NCT07365306 is a Phase 2 study that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07365306, a Phase 2 study, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Biopsy Procedure
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2026-04-15 |
| Est. Completion | 2029-10-15 |
| Phase | Phase 2 |
What NCT07365306 shows while recruiting
NCT07365306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07365306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07365306 about?
NCT07365306 is a clinical study titled "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". 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 ...
What is the current status of trial NCT07365306?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2026-04-15. Estimated completion is 2029-10-15.
What interventions are being tested in trial NCT07365306?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Biopsy Procedure (PROCEDURE), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT07365306?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07365306's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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