About this trial
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.
Eligibility criteria
Qualifiers
Patient aged ≥ 18 years at the time of signing informed consent.
Karnofsky Performance Status (KPS) ≥50 at the time of the screening visit.
AML with bone marrow blasts < 5%, absence of circulating blasts, and absence of extramedullary disease.
MDS
Disqualifiers
Potential treatment-arm patient is positive for HLA-A*02:07.
For patients with AML: those in third complete remission (CR3) or greater, partial remission, or with active AML disease.
If patient required hemodialysis or mechanical ventilation within 3 months prior to enrollment, circumstances must be discussed with the Sponsor Medical Monitor.
Prior allo-HCT.
Trial design
Treatments tested in this trial
- TSC-101
- Control