Phase I Study of CD45RA-depleted CD19-CAR T Cell Therapy After TCRCD19 B Cell-depleted Haploidentical Transplantation for Children and Young Adults With RelapsedRefractory CD19 B-cell Leukemia and Lymphoma

What this Trial Is About

Researchers are studying newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19-positive leukemia acute lymphoblastic leukemia ALL and lymphoma. This Phase I study aims to assess the safety and feasibility of adding CD19-CARMem T cells after a special type of haploidentical donor transplantation that removes certain T cells and CD19 B cells in pediatric patients with relapsed or refractory CD19-positive B-cell malignancies. The study also evaluates survival outcomes and immune-related side effects over time. Treatment involves a conditioning chemotherapy regimen including drugs such as Anti-Thymocyte Globulin, Fludarabine, Cyclophosphamide, Melphalan, Thiotepa, and Mesna. On day 0, patients receive an infusion of TCRb1b2CD19 B cell depleted progenitor cells collected from a suitable donor using the CliniMACS system. As early as day 14 after transplantation, patients receive the previously manufactured CD19-CARMem T cell product. Donors undergo two separate collections for stem cells and T cells for manufacturing the CAR T-cell product and possible donor lymphocyte infusion. Participants are closely monitored for safety and effectiveness of the CAR T-cell infusion, with collections of blood and other samples for research. The study measures safety outcomes within the first 100 days and feasibility within 60 days post-transplant. Long-term outcomes include survival rates, relapse, graft-versus-host disease, and immune-related adverse events over one to three years. The total participation duration may extend through follow-up assessments to evaluate these outcomes.

CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma