Safety and Effectiveness Study of CD19BCMA-targeted CAR-T Cells Combined With Dasatinib for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, Non-Hodgkins Lymphoma, and Multiple Myeloma

What this Trial Is About

Researchers are studying the safety and effects of CD19BCMA-targeted CAR-T cells combined with dasatinib in patients who have relapsed or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkins lymphoma, or multiple myeloma. This early phase 1 trial aims primarily to explore the safety of this combination treatment, enrolling 120 patients based on similar clinical trials from other countries. Participants will be randomly assigned to one of two groups one receiving CD19BCMA-targeted CAR-T cells combined with dasatinib, and the other receiving the CAR-T cells alone. The dasatinib is given in several ways including preconditioning during CAR-T cell manufacturing, and as intervention to manage side effects like cytokine release syndrome, neurotoxicities, and during the phase when CAR-T cells decrease. CAR-T cells are administered by intravenous infusion. Throughout the study, participants will be closely monitored for side effects and treatment responses. This includes tracking dose-limiting toxicity and treatment-emergent adverse events up to two years after infusion. Researchers will also evaluate overall response rates, survival outcomes, quality of life, and mental health at multiple time points up to two years. The total participation duration includes ongoing safety and effectiveness assessments over this period.

CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies