UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL (NCT04544592) | Clinical Trial Compass
RecruitingPhase 1/2
UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
United States45 participantsStarted 2021-03-10
Plain-language 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.
Who can participate
Age range31 Days – 30 Years
SexALL
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Inclusion Criteria:
* 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:
* 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 cr…
What they're measuring
1
Determine the safety and tolerability of UCD19 CAR-T infusion in pediatric patients with B-ALL or B-NHL
Timeframe: Post UCD19 infusion to Day 28
2
Determine the preliminary efficacy of UCD19 CAR-T cells in pediatric patients with B-ALL or B-NHL
Timeframe: Day 28 (for B-ALL) and Day 90 (for B-NHL) post UCD19 infusion