Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons).

NCT Number	NCT07216443
Lead Sponsor	Orca Biosystems, Inc.
Conditions	Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia
Enrollment	80 participants
Start Date	2025-12-09
Primary Completion	2027-11 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-07