The purpose of this study is to determine the safety of a cell therapy, T-allo10, after αβdepleted-HSCT in the hopes that it will boost the adaptive immune reconstitution of the patient while sparing the risk of developing severe Graft-versus-Host Disease (GvHD).
The primary objective of Phase 1a is to determine the recommended Phase 2 dose (RP2D) administered after infusion of αβdepleted-HSCT in children and young adults with hematologic malignancies.
A Phase 1b extension will occur after dose escalation, enrolling at the RP2D for the T-allo10 cells determined in the Phase 1 portion to evaluate the safety and efficacy of infusion of T-allo10 after receipt of αβdepleted-HSCT. Additionally, Phase 1b aims to explore improvements in immune reconstitution.
All participants on this study must be enrolled on another study: NCT04249830
1. Age > 1 months (with minimum weight of 10 Kg) and < 45 years.
2. Patients deemed eligible for allogeneic HSCT under the originating study, NCT 04249830
High-risk ALL in 1st CR, ALL in 2nd or subsequent CR;
High-risk AML in 1st CR, AML in 2nd or subsequent CR;
Not eligible to receive HSCT on NCT04249830
Received another investigational agent within 30 days of enrollment.
Pregnancy (positive serum or urine beta-HCG) within 7 days of MNC donation.
Patient or donor is not willing or able to undergo an additional non-mobilized apheresis for collection of MNC prior to donation of cells for participation in NCT04249830.
Porteus, Matthew, MD
Lead sponsor
Stanford University
Sponsor institution
California Institute for Regenerative Medicine (CIRM)
Collaborator