A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
Recruiting
Phase 3
Interventional Study
AML
MDS
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 310 (estimated)
- Sponsor
- TScan Therapeutics, Inc. · Industry
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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 …
Trial Locations
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Eligibility Criteria
Subject Inclusion Criteria:
1. Patient aged ≥ 18 years at the time of signing informed consent.
2. Karnofsky Performance Status (KPS) ≥50 at the time of the screening visit.
3. Undergoing first allo-HCT with a diagnosis of:
* AML with bone marrow blasts \< 5%, absence of circulating blasts, and…
Contacts