Odronextamab + CAR-T Cell Therapy for Diffuse Large B-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byJoseph M Tuscano

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, Davis

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for patients with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) that has either returned after treatment or hasn't responded to previous therapies. It's specifically for those who are candidates for CAR T-cell therapy, which is often used when other treatments don't work.

Inclusion Criteria

Life expectancy ≥ 3 months

Leukocytes ≥ 2,500/µL

Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)

+18 more

Exclusion Criteria

Pregnancy or lactation

Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she/they were to participate in the study or confounds the ability to interpret data from the study as determined by the study principal investigator (PI) or enrolling physician

I have not had major surgery in the last 4 weeks.

+15 more

Participant Groups

The study tests odronextamab, a dual-targeting antibody, given before and after standard CAR T-cell therapy in DLBCL patients. The goal is to see if this approach can boost the immune system's ability to fight cancer by helping T-cells identify and destroy B-cells involved in the disease.

1Treatment groups

Experimental Treatment

Group I: Treatment (odronextamab, CAR T-cell therapy)Experimental Treatment2 Interventions

Patients receive odronextamab IV over 1-4 hours on days 1, 2, 8, 9, 15, and 16 of cycle 1, on days 1, 8, and 15 of cycles 2-4 then on days 1 and 15 of subsequent cycles until achievement of durable CR. Cycles repeat every 21 days in the absence of durable CR, disease progression, or unacceptable toxicity. Patients with durable CR for ≥ 9 months may then receive odronextamab IV over 1-4 hours on day 1 of each subsequent cycle. These cycles repeat every 28 days for up to a total of 2 years in the absence of disease progression or unacceptable toxicity. Patients receive SOC CAR T-cell therapy if disease assessment shows less than a CR after cycle 4, or after cycle 5 if disease assessment shows PD any time after cycle 5.