A Phase 2 Trial of Nemtabrutinib in Combo With Brexu-cel for Patients With Relapsed/Refractory Mantle Cell Lymphoma

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT07673367
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Recurrent Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2032

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nemtabrutinib + brexu-cel
    PRE-CAR T PHASE (4-5 WEEKS): Starting 2 weeks before undergoing apheresis, patients receive nemtabrutinib orally (PO) once daily (QD) on days -40 to -6 in the absence of disease progression or unacceptable toxicity. Patients receive lymphodepleting chemotherapy fludarabine and cyclophosphamide on days -5 to -3. CAR T INFUSION PHASE (4-5 WEEKS): Patients receive brexu-cel IV on day 0. POST CAR T PHASE (UP TO 24 MONTHS): Starting around day 28 or later after brexu-cel infusion, patients without progressive disease (PD) receive nemtabrutinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 24 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free survival after brexucabtagene autoleucel (brexu-cel) infusion in relapsed/refractory mantle cell lymphoma [ Time Frame: From the day of brexu-cel infusion to the earlier of documentation of objective disease progression, initiation of any non-protocol anti-lymphoma therapy or death from any cause, assessed up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37203
Vanderbilt-Ingram Service Services for Timely Access
[email protected]
800-811-8480
Bhagirathbhai Dholaria (PRINCIPAL_INVESTIGATOR)

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By research site
Vanderbilt University/Ingram Cancer Center· Nashville, TN

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