RecruitingPhase 1NCT07257419

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

Sponsor

St. Jude Children's Research Hospital

Enrollment

60 participants

Start Date

Jun 3, 2026

Study Type

INTERVENTIONAL

Conditions

Hematologic Malignancy Relapsed Pediatric ALL Hematopoietic Cell Transplantation

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.

Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests a specialized cell therapy approach for children and young adults with relapsed or treatment-resistant B-cell leukemia or lymphoma. It combines a specific type of bone marrow transplant (from a partially matched donor) with re-engineered immune cells called CAR-T cells that are designed to target cancer cells expressing the CD19 protein. **You may be eligible if...** - You are 21 years old or younger - You have high-risk B-cell ALL, B-cell lymphoma, or certain other blood cancers expressing CD19 - Your disease has relapsed or did not respond to standard therapy - You are a candidate for a haploidentical (half-matched donor) stem cell transplant **You may NOT be eligible if...** - You have active serious infections - Your organ function does not meet required thresholds - You have significant heart or lung problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnti-Thymocyte Globulin (Rabbit)

Days -10, -11, -12.

DRUGCyclophosphamide

60 mg/kg intravenous once daily on day -9.

DRUGFludarabine

30 mg/m2 intravenous once daily for \>10 kg, 1 mg/kg intravenous once daily for ≤10 kg on days -4, -5, -6, -7, -8.

DRUGThiotepa

5 mg/kg intravenous twice daily on day -3.

DRUGMesna

Mesna is planned to be administered at 15 mg/kg/dose prior to cyclophosphamide and at approximately 3, 6, and 9 hours after the cyclophosphamide infusion, to give a 1:1 ratio of mesna:cyclophosphamide.

DRUGMelphalan

70 mg/m2 intravenous once daily for \>10 kg, 2.3 mg/kg intravenous once daily for ≤10 kg on days -1, and -2.

DRUGFilgrastim

G-CSF\* 10 mcg/kg/day SC days 0, -1, -2, -3, -4, -5.

DEVICECliniMACS System

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.