Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORCA-T · 1 trial · 4 indications
The proportion of patients who, at Day +100 have not experienced any severe transplant-related adverse events including non-relapse mortality (NRM), primary graft failure, acute GVHD (grade 2-4), acute GVHD grade 3-4, or opportunistic infections (grade 4-5).
| Arm | Type | Description |
|---|---|---|
| ORCA-T + (tacrolimus and ruxolitinib) | EXPERIMENTAL | Dual-agent tacrolimus starting on the day after Tcon infusion (Day +3 or Day +4) and ruxolitinib starting on the day after tacrolimus (Day +4 or Day +5). |
| Name | Type | Description |
|---|---|---|
| ORCA-T | DRUG | On Day 0, participants will receive an infusion of Orca-T HSPCs and Orca-T Tregs. On Day +2 or +3 (between approximately 48 to 72 hours of Day 0), patients will receive an infusion of the Orca-T Tcons. There is no dose escalation or de-escalation planned for the Orca-T investigational product. |
Inclusion Criteria: 1. Eligible diseases: * Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) as defined in Section 6.1.3; with or without the presence of known minimal residual disease, or * Myelodysplasic syndrom...
ORCA-T is an investigational small molecule being developed for Acute Myeloid Leukemia. It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied in patients with advanced hematologic malignancies undergoing allogeneic hematopoietic cell transplantation.
ORCA-T is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and efficacy in patients with Acute Myeloid Leukemia and other hematologic malignancies.
ORCA-T is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting patients and is designed to evaluate the drug in advanced hematologic malignancies, including Acute Myeloid Leukemia.
ORCA-T is being studied in a single Phase 1 clinical trial with the identifier NCT06551584. This trial is recruiting patients with Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, and Myelodysplastic Syndromes. The trial is enrolling 24 participants in the United States.
ORCA-T is a small molecule therapeutic. Its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential role in treating Acute Myeloid Leukemia and other hematologic malignancies, particularly in the context of allogeneic hematopoietic cell transplantation.