Clinical Trial

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

Active, Not Recruiting Phase 1
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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.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2012-09-07; most recent amendment 2026-06-03.
Status change: Recruiting → Active, Not Recruiting 2015-02-12
Status change: Active, Not Recruiting → Recruiting 2012-12-10
Status change: Not Yet Recruiting → Active, Not Recruiting 2012-11-30
Trial Details
NCT Number NCT01683279
Lead Sponsor Seattle Children's Hospital
Conditions B Cell Leukemia
Enrollment 6 participants
Start Date 2012-03-25
Primary Completion 2015-01-07 (estimated)
Study Completion 2030-01-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-05