Therapeutic strategy driven by residual disease for CARCIK-CD19 in patients with relapsed/refractory B cell precursor Acute Lymphoblastic Leukemia

Prior treatment

• GVHD Grades II-IV for patients who had previously been transplanted;
• Any cell therapy in the last 30 days;
• Patient with concomitant life-threatening infectious disease;
• Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met;

Other illness

• Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris and cardiac arrhythmia;
• Active Central Nervous System (CNS) involvement by malignancy, defined as CNS-3 per National Comprehensive Cancer Network (NCCN) guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible
• Patients with hepatic or renal disease as specific above;
• Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
• HIV/HBV/HCV Infection: Seropositive for HIV antibody. Seropositive for hepatitis C or positive for Hepatitis B surface antigen (HBsAG);

Other

• Lansky/Karnofsky score <60;
• Pregnant or breast feeding females;

• Children (1-17) and adults (18-75 years old);
• Absence of severe renal disease (creatinine > x 3 normal for age);
• Absence of severe hepatic disease (direct bilirubin > 3 mg/dl or SGOT > 500);
• Patient/guardian able to give informed consent.
• Relapsed or refractory adult and pediatric BCP-ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if <5%, with at least 1% of molecular disease at PCR;
• Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
• Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening, or if <5%, with at least 1% of molecular disease at PCR;
• No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
• No longer taking immunosuppressive agents for at least 30 days prior to infusion;
• No evidence of concomitant life-threatening infectious disease;
• Life expectancy > 60 days;
• Lansky/Karnofsky scores > 60;