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A Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia
Sponsor: Seattle Children's Hospital
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.
Official title: Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-05: A Phase 1 Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia
Key Details
Gender
All
Age Range
Any - 30 Years
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2017-11-03
Completion Date
2035-03-03
Last Updated
2025-12-15
Healthy Volunteers
No
Interventions
Patient-derived CD19- and CD22 specific CAR
Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt
Locations (5)
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Seattle Children's Hospital
Seattle, Washington, United States
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada