Anti-CD22-CAR m971-BBz Lentiviral Vector-Transduced Autologous T Lymphocytes in Treating Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia

Inclusion Criteria

• Signed informed consent form must be obtained prior to any research procedure
• Relapsed or refractory B-cell ALL: * 1st or greater bone marrow (BM) relapse OR * Any marrow relapse after allogeneic hematopoietic stem cell transplantation (HSCT) and > 100 days from transplant OR * For patients with refractory disease: ** < 60 years old that have not achieved a complete remission (CR) after > 2 or more chemotherapy regimens ** >= 60 years old that have not achieved a CR after 1 prior chemotherapy regimen
• Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed tyrosine kinase inhibitor therapy
• Patients with >= 5 white blood cells in the cerebrospinal fluid with blasts (CNS3) disease will be eligible if central nervous system (CNS) disease is responsive to therapy
• Documentation of CD22 expression on malignant cells at relapse
• Creatinine =< 1.6 mg/dl
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x upper limit of normal range
• Direct bilirubin =< 2.0 mg/dl
• Must have a minimum level of pulmonary reserve defined as =< grade 1 dyspnea, pulse oxygen > 92% on room air, and carbon monoxide diffusing capability test (DLCO) >= 40% (corrected for anemia)
• Left ventricle ejection fraction (LVEF) >= 40% confirmed by echocardiography (ECHO)/ multi gated acquisition scan (MUGA)
• Evidence of disease by standard morphologic or by minimal residual disease (MRD) criteria
• Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1
• No contraindications for leukapheresis
• Subjects of reproductive potential must agree to use acceptable birth control methods

Exclusion Criteria

• Active hepatitis B or active hepatitis C
• Human immunodeficiency virus (HIV) infection
• Class III/IV cardiovascular disability according to the New York Heart Association Classification
• Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
• Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy
• Concurrent use of systemic steroids or immunosuppressant medications; recent or current use of inhaled steroids or physiologic replacement with hydrocortisone is not exclusionary
• CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity
• Pregnant or nursing (lactating) women
• Receipt of a prior investigational study agent within 4 weeks prior to enrollment; *Note- patients who have received anti-CD19 CART cells (e.g. CART19/cytotoxic T lymphocyte [CTL] 019) on an investigational study where cell infusion occurred greater than 4 weeks before the screening visit are NOT excluded
• Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system