Inclusion Criteria:
- First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the
first 2 subjects were enrolled and treated); subsequent subjects <31 years.
- Diagnosis of CD19+22+ leukemia
- Disease status:
- If post allogeneic HCT: Confirmed CD19+CD22+ leukemia recurrence defined as at
least 0.01% disease following allogeneic HCT
- If relapse/refractory status with no prior history of allogeneic HCT, one of the
following:
- Second or greater marrow relapse, with or without extramedullary disease
- First marrow relapse at end of first month or re-induction with marrow having at
least 0.01 % blasts by morphology and/or MPF
- Primary refractory as defined as greater than 5% blasts by multi-parameter flow
after at least 2 separate induction regimens.
- Subject has indication for HCT but has been deemed ineligible, inclusive of
persistent MRD prior to HCT
- Asymptomatic from CNS involvement, if present, and in the opinion of the Principal
Investigator with 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 prior to
enrollment
- Lansky or Karnofsky performance score of at least 50
- Life expectancy of at least 8 weeks
- Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and
radiotherapy
- At least 7 days post last chemotherapy administration (excluding intrathecal
maintenance chemotherapy)
- At least 7 das post last systemic corticosteroids administration (unless physiologic
replacement dosing)
- No prior genetically modified cell therapy that is still detectable or virotherapy
- Adequate organ function
- Adequate laboratory values
- Willing to participate in long-term follow-up for up to 15 years, if enrolled in the
study and receive T cell infusion
- Patients of childbearing/fathering potential must agree to use highly effective
contraception from the time of initial T cell infusion through 12 months following the
last T cell infusion
Exclusion Criteria:
- Presence of active clinically significant CNS dysfunction
- Pregnant or breast-feeding
- Unable to tolerate apheresis procedure
- Presence of active malignancy other than CD19+CD22+ leukemia
- Presence of active severe infection
- Presence of any concurrent medical condition that, in the opinion of the Principal
Investigator, would prevent the patient from undergoing protocol-specified therapy
