A Phase 2 Trial of Nemtabrutinib in Combination With Brexu-cel for Patients With Relapsed/Refractory Mantle Cell Lymphoma
Vanderbilt-Ingram Cancer Center
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the impact of Nemtabrutinib on efficacy of brexu-cel in relapsed or refractory (R/R) mantle cell lymphoma (MCL). SECONDARY OBJECTIVES: I. To evaluate disease response rates and survival after brexu-cel. II. To evaluate the safety of Nemtabrutinib with brexu-cel. EXPLORATORY OBJECTIVES: I. Impact of nemtabrutinib on undetectable measurable residual disease (MRD) rate after brexu-cel. II. Impact of Nemtabrutinib biological activity on recipient immune repertoire. III. Impact of Nemtabrutinib in vivo brexu-cel kinetics. IV. Mechanism of disease relapse. OU…