RecruitingPhase 2NCT06854159

Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Therapy

A Phase 2 Study of Odronextamab in Relapsed/ Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Before and After Chimeric Antigen Receptor (CAR) T-Cell Therapy


Sponsor

Joseph Tuscano

Enrollment

34 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well odronextamab works before and after standard of care (SOC) chimeric antigen receptor (CAR) T-cell therapy in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR-T cell therapy is the SOC treatment most patients receive when other treatments have failed. CAR-T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Odronextamab is a monoclonal antibody that is called bispecific, as it individually targets 2 cell proteins, CD20 and CD3. Proteins are part of each cell in the body, which work together like little machines for the cell to function. CD20 is a protein that is found on the surface of both normal B-cells and B-cells that make up certain cancers, like DLBCL. CD3 is a protein that is found on the surface of T cells. T-cells and normal B-cells are types of white blood cells in the body and are a part of the immune system that fights infections. Odronextamab is designed to help T-cells find and kill the B-cells including the cancer cells in DLBCL. Giving odronextamab before and after CAR T-cell therapy may improve response in patients with relapsed or refractory DLBCL.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests odronextamab (a drug that helps the immune system attack cancer cells) before and after CAR-T cell therapy in people with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or stopped responding to prior treatments. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with relapsed or refractory DLBCL confirmed by biopsy - You have received and failed at least 2 prior treatments - You are a candidate for CAR-T cell therapy - You have adequate blood counts and organ function - You have a life expectancy of at least 3 months **You may NOT be eligible if:** - The cancer has spread to your brain or spinal cord - You have had a recent major surgery (within 4 weeks) - You have had a prior organ transplant - You have active uncontrolled infection - You have received a live vaccine within 28 days - You are pregnant or breastfeeding - You have known allergies to allopurinol or rasburicase Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALChimeric Antigen Receptor T-Cell Therapy

Receive CAR T-cell therapy

BIOLOGICALOdronextamab

Given IV


Locations(1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

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NCT06854159


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