drugset / Trial / NCT01683279

A Pediatric Trial of Genetically Modified Autologous T Cells Directed Against CD19 for Relapsed CD19+ Acute Lymphoblastic Leukemia

NCT01683279 ↗

Phase 1 Active not recruiting 6 enrolled Seattle Children's Hospital
NaSingle-groupOpen-labelTreatment

Summary

Patients with relapsed leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use a patient's own T cells, which can be genetically modified to expresses a chimeric antigen receptor(CAR). The CAR enables the T cell to recognize and kill the leukemic cells though the recognition of CD19, a protein expressed on the surface of the majority of pediatric ALL. This is a phase I study designed to determine the maximum tolerated dose of the CAR+ T cells and define the toxicity of the treatment. As a secondary aim, we will be looking at the efficacy of the T cells on eradicating the patient's leukemic cells.

Timeline

Start
2012-03-25
Primary completion
2015-01-07
Completion
2030-01-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous CD19 CAR+ EGFTt + T cells Cell therapy — Intravenous