Study of CD19 Allogeneic Memory T-cell Therapy for Relapsed/Refractory CD19+ Leukemia

Recruiting Phase 1 Interventional Study
Acute Lymphoblastic Leukemia, in Relapse Acute Lymphoblastic Leukemia, Refractory Pediatric ALL
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
Up to 21
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
St. Jude Children's Research Hospital · Other
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About This Trial
This is a Phase I clinical study evaluating the safety and maximum tolerated dose of a novel CAR T-cell product: allogeneic memory (CD45RA- negative) T-cells expressing a CD19-specific CAR 41BBz (CD19-CAR.CD45RA- negative T-cells) for the treatment of patients ≤ 21 years old with relapsed and/ or refractory CD19-positive leukemia. Primary Objective To determine the maximum tolerated dose (MTD) a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria Eligibility Criteria for Donors: Apheresis and Manufacturing * Age ≥ 18 years old * At least single haplotype matched (≥ 3/6) family member * HIV negative * For females of child bearing age: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior …
Contacts

Aimee C. Talleur, MD

866-278-5833

referralinfo@stjude.org

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