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drugset / Trial / NCT04640987

Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback

NCT04640987 ↗

Phase 1 Recruiting 22 enrolled Porteus, Matthew, MD California Institute for Regenerative Medicine (CIRM) · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2021-02-10
Primary completion
2027-03
Completion
2029-03

Drugs

EvaluationDrugModalityDoseRoute
Subject T-allo10 Cell therapy 100000 cells/kg Other
Subject T-allo10 Cell therapy 300000 cells/kg Other
Subject T-allo10 Cell therapy 1e+06 cells/kg Other

Indications

hematologic disorder