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Nemtabrutinib With CAR T Therapy in Relapsed/Refractory Mantle Cell Lymphoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Recruitment opened Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  3. Interventions: Nemtabrutinib (Drug) to Brexucabtagene autoleucel ( other names: brexu-cel , Tecartus) (Drug), Nemtabrutinib (Drug) Secondary endpoints revised (3) · Study title shortened, about 7 wordsv2 Show 2 more changesShow less
    • Secondary endpoints revised (3)
    • Study title shortened, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 the effect of nemtabrutinib in combination with brexucabtagene autoleucel (brexu-cel) in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Nemtabrutinib, a BTK inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chimeric antigen receptor (CAR) T-cell therapy, such as brexu-cel, 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. Chemotherapy, such as fludarabine and cyclophosphamide, are given before CAR T cell therapy to help kill cancer cells in the body and help make room for the CAR T cells. Giving nemtabrutinib in combination with brexu-cel may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.
Trial Details
NCT Number NCT07673367
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: Merck Sharp & Dohme LLC
Conditions Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov