Clinical Trial

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

Study acronym: Orca-T
Active, Not Recruiting Phase 3
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. This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2022-03-30; most recent amendment 2026-02-18.
Status change: Recruiting → Active, Not Recruiting 2024-05-24
Status change: Not Yet Recruiting → Recruiting 2022-04-18
Trial Details
NCT Number NCT05316701
Lead Sponsor Orca Biosystems, Inc.
Conditions Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, Undifferentiated Leukemia, Myelodysplastic Syndrome, Acute Leukemia, Therapy-Related Myelodysplastic Syndrome
Enrollment 187 participants
Start Date 2022-06-21
Primary Completion 2024-07-15 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-03-04