Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2034-12-01

Target enrollment:

Participant gender:

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 TCR+ depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies. Secondary Objectives: * To estimate 1-year post-transplant overall survival, relapse 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.

Phase:

PHASE1

Details

Lead Sponsor:

St. Jude Children's Research Hospital

Treatments:

Antilymphocyte Serum
Cyclophosphamide
Filgrastim
fludarabine
Granulocyte Colony-Stimulating Factor
Melphalan
Mesna
Thiotepa