Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TSC-101 · 1 trial · 2 indications
To determine the efficacy of TSC-101 by assessing relapse-free survival (RFS)
| Arm | Type | Description |
|---|---|---|
| Treatment Arm (TSC-101) | EXPERIMENTAL | Participants who are HLA-A\*02:01-positive and undergoing reduced intensity conditioning hematopoietic stem cell transplantation using allogeneic HLA-A\*02 negative donors. |
| Control Arm (Standard of Care) | ACTIVE_COMPARATOR | 1. Participants who are not HLA-A\*02:01-positive, HA-2-positive, or who are treatment-arm eligible but for whom an HLA-A\*02-negative donor cannot be identified, will be assigned to the control arm and receive allo-HCT alone. 2. Participants who are HLA-A\*02:01 negative, will be assigned to the control arm and receive allo-HCT alone. |
| Name | Type | Description |
|---|---|---|
| TSC-101 | DRUG | SOC + TSC-101 |
| Control | OTHER | SOC alone |
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...
TSC-101 is an investigational small molecule being developed for the treatment of acute myeloid leukemia (AML). It is currently in Phase 3 clinical development. The drug is being studied in patients undergoing allogeneic peripheral blood stem cell transplantation, with the trial also enrolling individuals with myelodysplastic syndromes (MDS).
TSC-101 is being developed by TScan Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol TCRX. The company is conducting a Phase 3 clinical trial of TSC-101 in the United States for patients with AML and MDS.
TSC-101 is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 3 trial is actively recruiting participants in the United States for patients aged 18 years and older with AML or MDS.
TSC-101 is being evaluated in a single Phase 3 clinical trial registered as NCT07702578. The study is titled "A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation" and is actively recruiting 310 participants with AML or MDS in the United States.
Yes, TSC-101 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. This designation is granted to regenerative medicine therapies intended to treat serious conditions. The drug remains investigational and is still in clinical development.
The Phase 3 clinical trial of TSC-101 is not randomized and is not double-blind. It is an active-controlled study, meaning participants receive an active comparator rather than a placebo. The trial is open to all sexes and does not require healthy volunteers.