Engineered immune cells target tough leukemia in early trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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