Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
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.
Timeline
- Start
- 2022-06-21
- Primary completion
- 2024-07-15
- Completion
- 2026-07
Outcome
Met primary endpoint
registry analysis (superiority test); Orca-T vs Standard of Care; p <0.00001; Hazard Ratio (HR) 0.26 (95% CI 0.14 to 0.47); Log Rank NCT05316701 ↗
paper Orca-T met the primary end point of improved survival free from cGVHD compared with Tac/MTX prophylaxis PMID 41385341 ↗
release “Precision-T study met the primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD)” orcabio.com ↗
release “In the randomized Precision-T study, Orca-T plus single-agent tacrolimus (TAC) demonstrated a significant improvement in the primary endpoint” orcabio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Orca-T | Cell therapy | — | — |
| Comparator | Standard-of-Care | Cell therapy | — | — |