Nemtabrutinib With CAR T Therapy in Relapsed/Refractory Mantle Cell Lymphoma
NCT07673367 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-08-05
Summary
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.
Conditions
- Recurrent Mantle Cell Lymphoma
- Refractory Mantle Cell Lymphoma
Interventions
- DRUG
-
Nemtabrutinib
Given PO
- DRUG
-
Brexucabtagene autoleucel ( other names: brexu-cel , Tecartus)
single IV administration
Sponsors & Collaborators
- collaborator INDUSTRY
-
Vanderbilt-Ingram Cancer Center
lead OTHER
Principal Investigators
-
Bhagirathbhai Dholaria · Vanderbilt University/Ingram Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2031-07-31
- Completion
- 2032-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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