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

Inclusion Criteria34

• Meets clinical criteria for leukapheresis or has a leukapheresis product previously collected and stored per recommended guidelines.
• 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); Pediatric patients will be included in age-appropriate discussions and assent will be obtained for those \> 7 years of age, when appropriate, according to institutional standards.
• Willingness to participate in long term follow up study.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Males OR non-pregnant, non-breastfeeding females.
• o Patients of child-bearing potential or capable of fathering a child must agree to use highly effective contraception from the time of initial CAR T cell administration though 12 months following the final administration of investigational product.
• Aged 31 days to 30 years (inclusive) at time of consent and enrollment.
• Acute Lymphoblastic Leukemia (ALL) OR Non-Hodgkin Lymphoma (NHL) of B-cell origin that:
• o Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both.
• Cohort One Criteria:
• Meets any one of the following conditions:
• Relapsed two or more times
• Relapsed at any time after allogeneic BMT
• Refractory to standard therapy as determined by the treating physician
• Meets criteria for BMT but is ineligible as determined by the treating physician
• Patient and/or parents declining BMT options and would prefer CAR-T Therapy.
• Non-Hodgkin Lymphoma includes all of the following:
• Diffuse large B-cell lymphoma (DLBCL)
• Burkitt Lymphoma
• Intermediate lymphoma between Burkitt and DLBCL
• Primary Mediastinal B-cell Lymphoma (PMBL)
• Follicular lymphoma
• High grade B cell lymphoma
• Transformed lymphoma
• Cohort Two Criteria:
• B-ALL in first relapse with any one of the following conditions:
• High-risk genomic alterations at initial diagnosis such as KMT2A gene rearrangement, t(17;19), hypodiploidy, Ph-like mutations, BCR-ABL1 fusion (Ph+ ALL), iAMP21, and TP53 inactivating mutation/deletion.
• Isolated CNS relapse such that cranial radiation would be indicated as a component of standard salvage therapy.
• Down syndrome.
• Minimal residual disease (MRD) positivity of \> 0.01% by FACS or \> 0 clonal sequences by NGS in bone marrow post re-induction chemotherapy.
• Age 18 years or older. OR
• Newly diagnosed with persistent MRD ≥ 0.01% by flow cytometry in bone marrow at end of consolidation.
• Performance score (Lansky or Karnofsky) of 50% or better;
• Unable to or declined to receive commercially available CD19 CAR-T Therapy.