NCT05316701

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Orca Biosystems, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cross reference NCT04013685

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Orca-T	an allogeneic stem cell and T-cell immunotherapy biologic
BIOLOGICAL	Standard-of-Care	unmanipulated donor allograft

Timeline

• Start date: 2022-06-21
• Primary completion: 2024-07-15
• Completion: 2026-07-01
• First posted: 2022-04-07
• Last updated: 2026-03-04
• Results posted: 2025-09-26

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study