UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
Trial Parameters
Brief Summary
This phase I/II trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.
Eligibility Criteria
Inclusion Criteria: 1. Meets clinical criteria for leukapheresis or has a 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); 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. 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-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