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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt
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
The adverse events associated with one or multiple CAR T-cell product infusions will be assessed
Type, frequency, severity, and duration of adverse events will be summarized
Time frame: 30 days
The number of successfully and unsuccessfully manufactured and infused CAR T-cell products will be assessed
Proportion of products successfully manufactured and infused
Time frame: 28 days
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