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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.
This is a Phase I study evaluating the addback of CD19-CAR(Mem) T cells after TCRαβ+/CD19 B cell depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies. Donors that meet eligibility criteria will be consented to undergo two separate collections: 1) G-CSF mobilized stem cell graft via apheresis for progenitor cell infusion and 2) Non-mobilized peripheral blood mononuclear cells (PBMC) via apheresis for subsequent CAR T-cell manufacturing and DLI if needed. Patients that meet eligibility criteria to receive therapy will be consented to proceed on study. Treatment will include a conditioning chemotherapy preparative regimen followed by infusion of TCRαβ/CD19 B cell depleted progenitor cell infusion on day 0. Then as early as day + 14 patients will receive the previously manufactured CD19-CAR(Mem) T cell product. Patients will then be monitored for safety and efficacy of the infused CAR T-cell product, as well as collection of correlative samples.
Age
0 - 21 years
Sex
ALL
Healthy Volunteers
No
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Start Date
March 3, 2026
Primary Completion Date
December 1, 2031
Completion Date
December 1, 2035
Last Updated
March 10, 2026
60
ESTIMATED participants
Anti-Thymocyte Globulin (Rabbit)
DRUG
Cyclophosphamide
DRUG
Fludarabine
DRUG
Thiotepa
DRUG
Mesna
DRUG
Melphalan
DRUG
Filgrastim
DRUG
CliniMACS System
DEVICE
Lead Sponsor
St. Jude Children's Research Hospital
NCT05529069
NCT07104799
Data Source & Attribution
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