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| Diagnosis | Leukemia, ALL, Acute Lymphoblastic Leukemia | Study Status | Open |
| Phase | I |
| Age | Child, Adult - (up to 30 Years) | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | IV |
| Last Posted Update | 2023-09-28 |
| ClinicalTrials.gov # | NCT03330691 |
International Sponsor
Seattle Children's Hospital
Principal Investigators for Canadian Sites
BC Children's Hospital – Dr. Kirk Schultz Centres
Medical contact
Rebecca Deyell
Social worker/patient navigator contact
Ilana Katz
Clinical research contact
Hem/Onc/BMT Clinical Trials Unit
Study Description
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.
Inclusion Criteria
- First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects: male and female subjects age ≥12 months of age and <27 years.
- Diagnosis of CD19+22+ leukemia relapsed or refractory
- Asymptomatic from CNS involvement
- Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment
- Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
- No prior genetically modified cell therapy that is still detectable or virotherapy
- Willing to participate in long-term follow-up for up to 15 years, if enrolled in the study and receive T cell infusion
Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.
