CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma

Inclusion Criteria:

- Male and female subjects age ≥ 1 and ≤ 26 years

- First 2 enrolled subjects: age ≥ 18 and ≤ 26 years

- Evidence of refractory or recurrent CD19+ leukemia or lymphoma

- Able to tolerate apheresis

- Life expectancy ≥ 8 weeks

- Lansky or Karnofsky 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

- 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