Clinical Trial

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

Recruiting Phase 1
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Summary
The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL. Primary Objective: \- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies. Secondary Objectives: * To estimate 1-year post-transplant overall survival, event-free survival, and GVHD-free relapse-free survival (GRFS). * To estimate cumulative incidence of engraftment, acute and chronic GVHD, and immune-related adverse events, including CRS and ICANS.
Protocol Amendment History 1 change
notable Enrollment increased: 60 -> 70 participants 2026-05-12
Trial Details
NCT Number NCT07257419
Lead Sponsor St. Jude Children's Research Hospital
Conditions Relapsed Pediatric ALL, Hematopoietic Cell Transplantation, Hematologic Malignancy
Enrollment 70 participants
Start Date 2026-08-03
Primary Completion 2031-12 (estimated)
Study Completion 2035-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-17