Clinical Trial

A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation

Study acronym: ALLOHA-2
Recruiting Phase 3
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Summary
This is a multicenter, genetically-randomized, controlled, Phase 3 study evaluating the efficacy and safety of T-cell receptor-engineered donor T cells targeting HA-2 (TSC-101) administered following reduced-intensity conditioning (RIC) hematopoietic cell transplantation (HCT) in participants with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). The study will compare TSC-101 plus standard of care (SOC) versus SOC alone in participants undergoing allogeneic peripheral blood stem cell transplantation from haploidentical or mismatched unrelated donors.
Protocol Amendment History 1 change
notable Trial sites expanded: 17 -> 26 locations 2026-07-23
Trial Details
NCT Number NCT07702578
Lead Sponsor TScan Therapeutics, Inc.
Conditions AML, MDS
Enrollment 310 participants
Start Date 2026-06-18
Primary Completion 2029-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-22