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

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 inci

Trial Details

NCT ID
NCT07257419
Phase
PHASE1
Sponsor
St. Jude Children's Research Hospital
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • Anti-Thymocyte Globulin (Rabbit)
  • Cyclophosphamide
  • Fludarabine
  • Thiotepa
  • Mesna
  • Melphalan
Locations (sample)
  • Memphis, Tennessee, United States|35.14953,-90.04898

Key Eligibility Criteria

  • Age less than or equal to 21 years
  • High risk hematologic malignancy where allogeneic transplantation is the current standard of care. This includes (but is not limited to):
  • High risk CD19+ B cell ALL in CR1 or CR2
  • Any CD19+ B-cell ALL in CR3 or subsequent

For full eligibility, visit ClinicalTrials.gov.

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