Clinical Trial

A Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia

Active, Not Recruiting Phase 1
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Summary
Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express two chimeric antigen receptors (CARs). One is to recognize CD19 and the other is to recognize CD22, both of which are proteins expressed on the surface of the leukemic cell in patients with CD19+CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through recognition of CD19 and CD22. This is a phase 1 study designed to determine the safety of the CAR+ T-cells and the feasibility of making enough to treat patients with CD19+CD22+ leukemia.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2017-11-01; most recent amendment 2025-12-05.
Status change: Recruiting → Active, Not Recruiting 2023-10-25
Status change: Active, Not Recruiting → Recruiting 2020-07-24
Status change: Recruiting → Active, Not Recruiting 2020-01-11
Status change: Not Yet Recruiting → Recruiting 2017-11-03
Trial Details
NCT Number NCT03330691
Lead Sponsor Seattle Children's Hospital
Conditions Leukemia, Lymphoma
Enrollment 78 participants
Start Date 2017-11-03
Primary Completion 2023-09-13 (estimated)
Study Completion 2035-03-03 (estimated)
Updated on ClinicalTrials.gov 2025-12-15