Clinical Trial

Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This study will evaluate the safety, tolerability, and efficacy of Orca-T, 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) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2019-07-08; most recent amendment 2026-05-29.
Status change: Recruiting → Active, Not Recruiting 2024-05-24
Status change: Not Yet Recruiting → Recruiting 2019-12-03
Trial Details
NCT Number NCT04013685
Lead Sponsor Orca Biosystems, Inc.
Conditions Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Acute Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Myeloid Leukemia
Enrollment 155 participants
Start Date 2019-11-21
Primary Completion 2025-04-30 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-14