Study Comparing Sequential CD19 and CD22 CAR T-Cell Therapy Versus Single CD19 CAR T-Cell Therapy with Stem Cell Transplant for Children and Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating treatments for children, adolescents, and young adults with relapsed or refractory B-cell Acute Lymphoblastic Leukemia B-ALL. This non-randomized, open-label trial compares the effectiveness of two treatment approaches sequential infusions of CD19 and CD22 CAR T cells versus CD19 CAR T cell infusion followed by hematopoietic stem cell transplantation HSCT. The goal is to understand which approach offers better event-free survival for patients aged 1 to 70 years with this condition. Participants may choose between three groups sequential treatment with CD19 and CD22 CAR T cells, CD19 CAR T cell infusion followed by HSCT, or CD19 CAR T cell infusion alone without additional consolidation therapy. The study will monitor the treatments over time, including the levels of CAR T cells in the body and the presence of leukemia cells. Treatments involve infusions of genetically modified immune cells designed to target cancer cells and, for some, a transplant procedure to replace bone marrow. During the trial, participants will undergo regular assessments including laboratory tests to measure leukemia response, monitoring of CAR T cell levels, and evaluation of side effects. The main outcome measured is event-free survival over two years, with additional long-term follow-up up to 15 years to observe overall survival, duration of response, and safety. Participants will be closely monitored throughout the treatment and follow-up periods to collect this information.

Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients