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

Recruiting now · Phase 3

Conditions studied: AML, MDS

In brief

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.

Key facts

Study ID

NCT07702578

Run by

TScan Therapeutics, Inc.

People needed

310

Starts

2026-06-18

Expected to finish

2029-06-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Froedtert & Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Sarah Cannon Research Institute - TriStar Bone Marrow Transplant (BMT) — Nashville, Tennessee, United States (enrolling)
• St. David's South Austin Medical Center — Austin, Texas, United States (enrolling)
• Baylor University Medical Center — Dallas, Texas, United States (enrolling)
• The University of Texas - MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• University of Colorado - Anschutz Cancer Center — Aurora, Colorado, United States (enrolling)
• SCRI - Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• Yale — New Haven, Connecticut, United States (enrolling)
• Memorial Cancer Institute — Hollywood, Florida, United States (enrolling)
• Moffitt Cancer Institute — Tampa, Florida, United States (enrolling)
• Northside Hospital — Atlanta, Georgia, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute - Hematology/Oncology — Boston, Massachusetts, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Mount Sinai Hospital — New York, New York, United States (enrolling)
• Columbia University - Irving Medical Center — New York, New York, United States (enrolling)
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Honor Health Cancer Transplant Institute — Scottsdale, Arizona, United States
• Banner Health - MD Anderson Cancer Center — Gilbert, Arizona, United States
• Stanford - School of Medicine — Stanford, California, United States
• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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