drugset / Trial / NCT05473910
A Phase 1 Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating dose regimen of up to 2 doses of TSC-100 and TSC-101 in patients with AML, MDS, or ALL following HCT from a haploidentical donor, MMUD, or MUD
Timeline
- Start
- 2022-11-01
- Primary completion
- 2026-06-01
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TSC-100 | Cell therapy | — | Intravenous |
| Subject | TSC-101 | Cell therapy | — | Intravenous |