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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site contact updatedv6
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Lead sponsor: Joseph Tuscano to University of California, Davis
    • Primary completion date: Feb 1, 2029 to Oct 2028
    • Study completion date: Apr 2029 to Jan 2029
    • Site contact updated
    v4
  4. Notable Lead sponsor: University of California, Davis to Joseph Tuscanov3
  5. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Apr 1, 2025 to Aug 7, 2025
    • Primary completion date: Oct 1, 2028 to Feb 1, 2029
    • Study completion date: Jan 2029 to Apr 2029
    • Site details revised
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06854159
Lead Sponsor University of California, Davis
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)
Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Related terms Lymphoma, Large B-Cell, Diffuse
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov