NCT01860937

T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adult Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

A Phase I Trial of T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adult Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 26 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of giving the patient special cells made from their own blood called "Modified T-cells". The goal is to find a safe dose of modified T-cells for patients whose leukemia has returned to the bone marrow.

Detailed description

This is a phase I multicenter clinical trial for pediatric and young adult patients with relapsed/refractory CD19+ B-ALL. The T cell doses originally proposed in this study were based on doses administered safely in prior T cell adoptive therapy trials, but the dose has been modified based on the toxicities observed in adult patients with morphologic evidence of relapsed B-ALL treated on MSKCC IRB 09-114.

Conditions

• Relapsed B-Cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
PROCEDURE	leukapheresis or collection of PBMCs
DRUG	cyclophosphamide based chemotherapy regimens
BIOLOGICAL	modified T cells

Timeline

• Start date: 2013-05-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2013-05-23
• Last updated: 2025-06-05

Locations

2 sites across 1 country: United States