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

Study acronym: ALLOHA-2
StatusRecruiting
PhasePhase 3
Started2026-06-18
View on ClinicalTrials.gov ↗

Amendment history

2026-07-20
Study Identification, Study Status, Contacts/Locations v2
Trial sites expanded: 17 → 26 locations
Study title-8 characters
A Phase 3 Study of T-Cell Receptor Engineered Donor T Cells in Subjec [...]
2026-07-16
Study Identification, Study Status v1
Study title-13 characters
A Phase 1-3 Study of T-Cell Receptor Engineered Donor T Cells in Subje [...] rgoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)
2026-07-08
Original filing
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.
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