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

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.

Conditions

• Relapsed Pediatric ALL
• Hematopoietic Cell Transplantation
• Hematologic Malignancy

Interventions

DRUG

Anti-Thymocyte Globulin (Rabbit)

Days -10, -11, -12.

DRUG

Cyclophosphamide

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

DRUG

Fludarabine

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.

DRUG

Thiotepa

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

DRUG

Mesna

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.

DRUG

Melphalan

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

DRUG

Filgrastim

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

DEVICE

CliniMACS 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Swati Naik, MBBS · St. Jude Children's Research Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-03

Primary Completion

2031-12-31

Completion

2035-12-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations