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 cell therapy being developed by TScan Therapeutics, Inc. for acute myeloid leukemia (AML). It is currently in Phase 3 clinical development and has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. It is not yet approved for commercial use.
TSC-101 is being studied for use in patients with acute myeloid leukemia (AML), specifically in the setting of allogeneic peripheral blood stem cell transplantation. The Phase 3 trial also enrolls patients with myelodysplastic syndromes (MDS). It is an investigational therapy and has not been approved for any indication.
TSC-101 is being developed by TScan Therapeutics, Inc., a biotechnology company whose common stock trades on the Nasdaq under the ticker symbol TCRX. TScan Therapeutics is the sponsor of the ongoing clinical program for TSC-101.
TSC-101 is in Phase 3 clinical development. The single registered trial for TSC-101 is a Phase 3 study that is currently active but no longer recruiting participants. TSC-101 has not been approved by the FDA and remains an investigational therapy.
TSC-101 is being evaluated in one registered clinical trial, NCT07702578, titled "A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation." The trial is a Phase 3, active-controlled study with an estimated enrollment of 310 participants, conducted in the United States, and is currently active but not recruiting.
TSC-101 has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. This designation is separate from FDA approval, and TSC-101 remains an investigational product in Phase 3 clinical development for AML and MDS.