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Orca-T
- Development stage
- Unknown
- Lead developer
- Orca Biosystems
- Modality
- Stem Cell Therapies → Cell Therapies
- Administration
- Intravenous
01
Overview
Orca-T (TRGFT-201) is an investigational high-precision allogeneic cell therapy developed by Orca Biosystems, designed to replace a patient's diseased blood and immune system with a healthy one while minimizing the risks of graft-versus-host disease (GvHD). The product is a proprietary graft composition consisting of purified donor-derived hematopoietic stem and progenitor cells (HSPCs), regulatory T cells (Tregs), and conventional T cells (Tcons). By precisely controlling the ratio and purity of these cell types, Orca-T aims to improve patient outcomes in hematopoietic stem cell transplantation (HSCT) for hematologic malignancies such as acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS). It is currently being evaluated in a Phase 3 pivotal trial (Precision-T) and in various Phase 1b studies, including one at City of Hope Medical Center evaluating Orca-T following escalated doses of total marrow and lymphoid irradiation (TMLI) with chemotherapy conditioning.
- Other names
- Partially Engineered T-regulatory Cell Donor Graft TRGFT-201
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