drugset / Trial / NCT07257419
CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-08-03
- Primary completion
- 2031-12
- Completion
- 2035-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 15 mg/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 1 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 2.3 mg/kg | Intravenous |
| Background | Melphalan | Small molecule | 70 mg/m2 | Intravenous |
| Background | Thiotepa | Other / unclassified | 5 mg/kg | Intravenous |
| Background | Thymoglobulin | Protein / enzyme biologic | — | — |
| Background | filgrastim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |