Dose Optimization Trial of CD19 Redirected Autologous T Cells

Inclusion Criteria

• Documented CD19+ CLL or SLL
• Successful test expansion of T-cells
• At least 2 prior chemotherapy regimens, not including single agent monoclonal antibody (rituxan) therapy. Single agent ofatumumab will be counted as a regimen. -Patients with high risk disease manifested by deletion chromosome 17p will be eligible if they fail to achieve a CR to initial therapy or progress within 2 years of 1 prior regimen.
• Patients who progress within 2 years after the second or higher line of therapy will be eligible. For instance, patients who had progression /= 18 years
• Adequate organ system function including:
• Creatinine 40%
• Gives voluntary informed consent

Retreatment Inclusion Criteria

• Performance Status 0-1
• Adequate organ system function including:
• Creatinine 40%
• No contraindications for leukapheresis (if required for retreatment)
• Gives voluntary informed consent for retreatment

Exclusion Criteria

• Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
• Uncontrolled active infection
• Active hepatitis B or hepatitis C infection
• Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
• Any uncontrolled active medical disorder that would preclude participation as outlined
• HIV infection
• Patients with active CNS involvement with malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment.
• Class III/IV cardiovascular disability according to the New York Heart Association Classification

Retreatment Exclusion Criteria

• Pregnant or lactating women. Female study participants must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
• Uncontrolled active infection
• Active hepatitis or hepatitis infection
• Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
• Any uncontrolled active medical disorder that would preclude participation as outlined.
• HIV infection
• Patients with active CNS involvement with malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment on the retreatment cohort.
• Class III/IV cardiovascular disability according to the New York Heart Association Classification