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...