UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL

Eligibility Criteria

• 1. Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines;
• 2. Provision of signed and dated consent form from parent or guardian (patients \<18), the patient themselves (\>18), or legally authorized representative (patient \>18 who lack decision-making capacity);
• 3. Willingness to participate in long-term follow-up study;
• 4. Stated willingness to comply with all study procedures and be available for the duration of the study;
• 5. Males OR non-pregnant, non-lactating females;
• 6. Aged 31 days to 30 years (inclusive) at time of consent and enrollment;
• 7. Acute Lymphoblastic Leukemia (ALL) OR Non-Hodgkin Lymphoma (NHL) of B-cell origin that:
• * Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both ;
• * Meets any one of the following conditions:
• * Non-Hodgkin Lymphoma includes all of the following:
• 8. Performance score (Lansky or Karnofsky) of 50% or better;
• 9. Unable to receive commercially available CD19 CAR-T Therapy.
• 1. Active, uncontrolled CNS leukemia or lymphoma, as clinically indicated, at eligibility, prior to lymphodepleting chemotherapy (LD chemo), and pre-cell infusion;
• 2. Active Graft-versus-Host Disease (GvHD);
• 3. Active, uncontrolled, life threatening infection that at the determination of the treating physician would preclude safe leukapheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or cytokine release syndrome;
• 4. Evidence of severe organ dysfunction that at the determination of the treating physician would preclude safe leukapheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or cytokine release syndrome including any of the following:
• * Myocardial dysfunction (based on age standards)
• * Baseline oxygen saturation of \< 90% on room air
• * Diffusion capacity of the lungs for carbon monoxide (DLCO) \< 40%, as determined within 45 days before cell infusion
• * Transaminases \> 10x upper limit of normal (ULN) or bilirubin \>2x the ULN, unless thought to be related to primary disease
• * Estimated Cr clearance \<60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)
• 5. Post-pubertal females that are pregnant, planning to become pregnant, or unwilling to use birth control (includes abstinence) for the study duration;
• 6. Known HIV infection, or active Hepatitis B or active Hepatitis C infection;
• 7. Prior gene therapy, including prior CAR-T cell.