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):

• If post-allogeneic hematopoetic cell transplant (HCT): confirmed CD22+ leukemia recurrence, defined as ≥0.01% disease
• 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
• 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

Exclusion criteria

• Presence of active clinically significant CNS dysfunction
• Pregnant or breastfeeding
• Unable to tolerate apheresis procedure, including placement of temporary apheresis line if required
• Presence of active malignancy other than CD22+ leukemia or lymphoma
• Presence of active severe infection
• Presence of any concurrent medical condition that would prevent the patient from undergoing protocol-based therapy
• Presence of primary immunodeficiency/bone marrow failure syndrome
• Unwilling to participate in 15-year follow-up period that is required if CAR T cell therapy is administered