A Phase I Trial of Donor- Derived 19-28z CAR T Cells Following Allogeneic Transplant for the Treatment of CD19 Malignancies

Inclusion Criteria

• •The following criteria must be met prior to the allogenic transplantation:
• •1. ALL in second remission or greater (≥ CR2)
• •* Please refer to section 3.0 for more discussion of ALL in CR1 versus CR2
• •2. CLL
• •1. High risk in any remission status as defined by 17p deletion or Richter's transformation, or
• •2. All other patients eligible after at least 2 lines of standard or investigational chemotherapy
• •3. B-NHL
• •1. Refractory or stable disease to last line of therapy per ICML 2014. Patients should have at least 2 lines of prior therapy.
• •2. Relapsed disease in patients who are not candidates for autologous transplant
• •4. Patient's age is ≥ 18 and ≤ 60.
• •5. KPS ≥ 70%
• •6. Patients must have CD19 expression (by any detection method) demonstrated on their malignant cells at the time of enrollment on the protocol.
• •7. Patients relapsed after prior CD19 CAR T cell or blinatumomab are eligible for enrollment as long as CD19 expression is still prese on the malignant cells.
• •8. Patients who have a matched related donor willing to donate HSC for allograft and PBMC for CAR T cell generation
• •9. Patients must have adequate organ function measured by:
• •1. Cardiac: asymptomatic or if symptomatic then LVEF at rest must be \> 50%
• •2. Hepatic: \< 3x ULN ALT and \< 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
• •3. Renal: serum creatinine \<1.3 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 60 ml/min (measured or calculated/estimated)
• •4. Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin)
• •5. Negative serum pregnancy test for women of child-bearing potential is required