OncRef

Clinical Trial: NCT05316701

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Orca Biosystems, Inc.
Information Provided By:Orca Biosystems, Inc.
Last Update Posted:2026-03-04

Study Overview

Brief 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.

Official Title

A Randomized Phase III Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Either Orca-T, a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells, or Standard-of-Care Allogeneic Graft

Conditions

Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, Undifferentiated Leukemia, Myelodysplastic Syndrome, Acute Leukemia, Therapy-Related Myelodysplastic Syndrome

Intervention / Treatment

  • Biological: Orca-T
  • Biological: Standard-of-Care

Other Study ID Numbers

  • Precision-T (PhIII component)

Start Date (Actual)

2022-06-21

Primary Completion Date (Actual)

2024-07-15

Study Completion Date (Estimated)

2026-07

Enrollment (Actual)

187

Study Type

Interventional

Phase

Phase 3