Modified Immune Cells (CD22-Specific CAR T Cells) for the Treatment of Refractory or Recurrent CD22+ Leukemia or Lymphoma, PLAT-07 Study

Inclusion Criteria

• Subjects age =< 30 years. The first two enrolled subjects must be >= 18 years of age
• Evidence of refractory or recurrent CD22+ leukemia or lymphoma as indicated by: * Leukemia (must meet at least one of the below criteria): ** If post-allogeneic hematopoietic stem cell transplant (HCT): *** Recurrence defined as >= 0.01% disease in the marrow, OR *** Recurrent isolated extramedullary disease ** If no history of allogeneic HCT, one of the following: *** Second or greater relapse, with or without extramedullary disease (subjects with isolated extramedullary disease are eligible) *** First marrow relapse at end of 1st month of re-induction with marrow having >= 0.01% blast by morphology and/or multiparameter flow cytometry (MPF), with or without extramedullary disease *** Primary refractory as defined as having > 5% disease in the marrow by MPF after 2 or more separate induction regimens, OR *** Subject has indication for allogeneic HCT but has been deemed ineligible, including subjects who have persistent MRD prior to HCT ** If previously treated with B cell antigen targeting chimeric antigen receptor (CAR) T cell immunotherapy, subject meets one of the following: *** Evidence of persistent or recurrent CD22+ leukemia at any point after infusion of prior CAR T cell product * Lymphoma (must meet at least one of the below criteria) ** Relapsed and/or refractory with no known curative therapy available, defined as one of the following: *** Relapsed or refractory disease after >= 2 treatment regimens including, at a minimum: **** Anti-CD20 monoclonal antibody (unless tumor is determined to be CD20 negative or the subject has a diagnosis of lymphoblastic lymphoma) **** Anthracycline-containing regimen *** Not eligible to proceed with an autologous transplant secondary to disease status or other medical reason *** Relapsed or refractory disease post-autologous or allogenic transplant ** If previously treated with B cell antigen targeting CAR T cell immunotherapy, subject meets one of the following: *** Evidence of persistent or recurrent CD22+ lymphoma at any point after infusion of prior CAR T cell product
• Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product
• Life expectancy >= 8 weeks
• Lansky performance status score of >= 50 for subjects < 16 years of age or Karnofsky score >= 50 for subjects >= 16 years. Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status
• If a subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of CAR T cells, the subject must discontinue all anti-cancer agents and radiotherapy and, in the opinion of the investigator, have fully recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy: * Chemotherapy and biologic agents: All chemotherapy and biologic therapy not specifically mentioned below must be discontinued >= 7 days prior to enrollment, with the exception of intrathecal chemotherapy and maintenance chemotherapy (for the subset of subjects who relapse during maintenance), both of which may be administered at any point pre-enrollment * Steroid use: All systemically administered (i.e. orally [PO] or IV) corticosteroid therapy (unless physiologic replacement dosing) must be discontinued >= 7 days prior to enrollment * Tyrosine kinase inhibitor (TKI) use: All TKIs must be discontinued >= 3 days prior to enrollment * Hydroxyurea: must be discontinued >= 1 day prior to enrollment * Prior CAR T cell therapy: must be at least 30 days from most recent CAR T cell infusion
• Serum creatinine =< 1.5 x the upper limit of normal (ULN) based on the following: Maximum serum creatinine (mg/dL) 1 to < 2 yrs: 0.6 (male and female) 2 to < 6 yrs: 0.8 (male and female) 6 to <10 yrs: 1 (male and female) 10 to < 13 yrs: 1.2 (male and female) 13 to < 16 yrs: 1.5 (male), 1.4 (female) >= 16 yrs: 1.7 (male), 1.4 (female)
• Hepatic: Total bilirubin =< 3 times ULN for age OR conjugated bilirubin =< 2 mg/dL AND alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 times ULN
• Cardiac: Shortening fraction >= 28% OR ejection fraction >= 50% as measured by echocardiogram
• Respiratory: Oxygen saturation >= 90% on room air without supplemental oxygen or mechanical ventilation
• Subjects requiring apheresis: Absolute lymphocyte count (ALC) >= 100 cells/uL
• Virology testing negative within 3 months prior to enrollment, to include: * Human immunodeficiency virus (HIV) antigen & antibody * Hepatitis B surface antigen * Hepatitis C antibody OR if positive, Hepatitis C PCR is negative
• If subject is of child-bearing or child-fathering potential, must agree to use highly effective contraception from the time of initial consent through 12 months following the infusion of investigational product on this trial
• Subject and/or legally authorized representative has signed the informed consent form for this study

Exclusion Criteria

• Active malignancy other than disease under study
• History of symptomatic central nervous system (CNS) pathology or ongoing symptomatic CNS pathology requiring medical intervention, including paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder (subjects with non-febrile seizure disorder controlled on anti-epileptic medication and without seizure activity within 3 months are eligible)
• 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
• Subjects with uniform expression of CD19 on their malignant cells who are eligible but have not attempted CD19 directed CAR T cell therapy
• If history of allogeneic stem cell transplant: active graft versus host disease (GVHD), or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
• Presence of active severe infection, defined as: * Positive blood culture within 48 hours of enrollment, OR * Fever above 38.2 degrees Celsius, AND clinical signs of infection within 48 hours of enrollment
• 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 subject from undergoing treatment under this protocol