Phase 13 Study of Engineered Donor T Cells Targeting HA-1 and HA-2 in Adults Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation for AML, MDS, or ALL

What this Trial Is About

Researchers are investigating a new treatment approach for patients with acute myeloid leukemia AML, myelodysplastic syndromes MDS, or acute lymphoblastic leukemia ALL who are undergoing allogeneic peripheral blood stem cell transplantation from haploidentical donors or matched unrelated donors. This Phase 1 study aims to evaluate the safety, feasibility, and early effectiveness of genetically engineered donor T cells called TSC-100 and TSC-101, which target specific minor antigens, combined with standard care compared to standard care alone. The study uses a multi-arm design and includes dose escalation to find the best tolerated dose. Participants will receive either TSC-100 or TSC-101 based on their genetic markers along with the standard transplant care, which includes reduced intensity conditioning and graft-versus-host disease prevention. The TSC products will be given intravenously in up to two doses, with dosing cohorts following a 33 escalation design to evaluate safety before moving to higher doses. Standard care regimens vary but may include chemotherapy combinations and supportive care as needed. Patients not receiving the investigational T cells will receive standard care alone as a control group. During the study, participants will be monitored for side effects and adverse events over two years, including dose-limiting toxicities. Researchers will also assess disease-free survival and relapse rates up to two years after transplant. Assessments include blood and bone marrow sampling, immune monitoring, and long-term follow-up for up to 15 years for those receiving the investigational T cell infusion. The study involves regular visits for treatment, safety monitoring, and data collection to understand the impact of the new therapy.

A Phase 1/3 Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation