Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies

Inclusion Criteria

• •Must have relapsed or refractory non-Hodgkin lymphoma (NHL) (Group A - NHL/CLL), chronic lymphocytic leukemia (Group A - NHL/CLL) or acute lymphoblastic leukemia (Group B - ALL) treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen.
• •The participant's malignancy is CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease.
• •Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
• •Total bilirubin ≤ 1.5 times the institutional upper limit of normal unless bilirubin rise is due to Gilbert's syndrome (maximum 2 time normal) or of non-hepatic origin
• •AST (SGOT) ≤ 3 times institutional upper limit of normal
• •ALT (SGPT) ≤ 3 times institutional upper limit of normal
• •Serum Creatinine ≤ 2 times the institutional upper limit of normal and creatinine clearance ≥ 30 mL/min (calculated or measured)
• •Must have adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.
• •Must have adequate cardiac function as defined as left ventricular ejection fraction≥ 40% in the most recent echocardiogram.
• •Absolute Lymphocyte Count \>100/microliter (uL)
• •Participants (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.
• •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period and for at least 90 days after the human anti-CD19 CAR-T cell infusion. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
• •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 6 months after the human anti-CD19 CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the human antiCD19 CAR-T cell infusion to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods