Clinical Research Directory

Inclusion Criteria: * Male and female subjects age ≥ 1 and ≤ 30 years * First 2 enrolled subjects: age ≥ 18 and ≤ 30 years * Disease requirements: * Phase 1: Evidence of refractory or recurrent CD19+ leukemia or lymphoma following previous CAR T cell immunotherapy * Phase 2: Evidence of refractory or recurrent CD19+ leukemia or lymphoma * Able to tolerate apheresis, or has sufficient existing apheresis product or T cells for manufacturing investigational product * Life expectancy ≥ 8 weeks * Lansky or Karnofsky, as applicable, score ≥ 50 * Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy, if the subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of CAR T cells * ≥ 7 days post last chemotherapy and biologic therapy, with the exception of intrathecal chemotherapy and maintenance chemotherapy * No prior virotherapy * ≥ 7 days post last corticosteroid therapy * ≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use * ≥ 1 day post hydroxyurea * 30 days post most recent CAR T cell infusion * Adequate organ function * Adequate laboratory values, including absolute lymphocyte count ≥ 100 cells/uL * Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial * Subject and/or legally authorized representative has signed the informed consent form for this study Exclusion Criteria: * Presence of active malignancy other than disease under study * History of symptomatic CNS pathology or ongoing symptomatic CNS pathology * CNS involvement of leukemia or lymphoma that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and CAR T cell infusion * Presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment * Presence of active severe infection * Presence of primary immunodeficiency syndrome * Subject has received prior virotherapy * Pregnant or breastfeeding * Subject and/or legally authorized representative unwilling to provide consent/assent for participation in the 15-year follow up period, required if CAR T cell therapy is administered * Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol