Study Comparing Stem Cell Transplant or Not After CD19 CAR-T S1904 Therapy for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Relapsed or refractory B-cell acute lymphoblastic leukemia RR B-ALL often has poor prognosis with traditional salvage chemotherapy. Researchers are studying a targeted immunotherapy called SenlB19 autologous CAR-T S1904 treatment, which has shown high remission rates but short remission duration and high relapse risk. This study aims to evaluate whether adding an allogeneic hematopoietic stem cell transplant allo-HSCT after CAR-T treatment improves long-term survival and safety for RR B-ALL patients. Participants will first receive the SenlB19 autologous CAR-T S1904 treatment. Those achieving bone marrow leukemia-free state and negative minimal residual disease within 12 weeks post-infusion will be randomly assigned to either a group receiving allo-HSCT transplant after CAR-T therapy or a group not receiving the transplant, in a 21 ratio. This setup allows comparison of outcomes with or without the bridging transplant. During the study, participants will be followed for an average of two years after randomization. Researchers will assess event-free survival, relapse-free survival, overall survival, and cumulative relapse incidence. The study includes regular monitoring of disease status and safety to understand the long-term effects of CAR-T therapy with or without allo-HSCT. The total participation duration varies but includes at least two years of follow-up.

Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T (S1904) Cell Therapy for r/r B-cell Acute Lymphoblastic Leukemia