A Phase 1 Study of CD22-CAR TCell Immunotherapy for CD22+ Leukemia and Lymphoma

Inclusion Criteria

• •First 3 subjects: male and female subjects age ≥ 18 years and \< 27 years
• •Subsequent subjects: 12 months of age and \<27 years of age at the time of study enrollment
• •Disease status (one of the following):
• •1. If post-allogeneic hematopoetic cell transplant (HCT): confirmed CD22+ leukemia recurrence, defined as ≥0.01% disease
• •2. If Relapse/Refractory status with no prior history of allogeneic HCT, one of:
• •* 2nd or grater marrow relapse, with or without extramedullary disease
• •* 1st marrow relapse at end of 1st month of re-induction with marrow having ≥0.01% blasts by morphology and/or MPF
• •* Primary Refractory, defined as \>5% blasts by multi-parameter flow after ≥2 separate induction regimens
• •* Subject has indication for HCT but is ineligible, inclusive of persistent minimal residual disease
• •3. CD22+ Lymphoma refractory or relapsed with no known curative therapies available
• •Asymptomatic from CNS involvement, if present, and have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T-cell infusion. Subjects with significant neurologic deterioration will not be eligible for T-cell infusion until stabilized.
• •Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks.
• •Lansky or Karnofsky performance score of ≥50
• •Life expectancy of \>8 weeks
• •Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
• •≥7 days post last chemotherapy administration (excluding intrathecal or maintenance chemotherapy)
• •≥7 days post last systemic corticosteroid administration
• •No prior virotherapy
• •Adequate organ function
• •Adequate laboratory values
• •Patients of childbearing/fathering potential must agree to use highly effective contraception
• •Signed a written consent