NCT07216443

Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Orca Biosystems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is 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).

Detailed description

This study is a multicenter, open-label phase 2 trial of Orca-T in adults with acute myeloid leukemia or myelodysplastic syndrome who are not able to receive myeloablative (high intensity) conditioning and are eligible for reduced intensity conditioning (RIC)-alloHCT or non-myeloablative (NMA)-alloHCT with an 8/8 human leukocyte antigen (HLA)-matched related or unrelated donor. The trial is designed to further characterize the safety and tolerability of Orca-T and to perform an initial assessment of the efficacy of Orca-T in participants eligible for RIC-alloHCT or NMA-alloHCT. Participants will receive Orca-T after the investigator's choice from the RIC and NMA regimens followed by single-agent graft-versus-host disease (GVHD) prophylaxis with tacrolimus. Prior to the initiation of this study (the SERENE-T Study), a phase 1 study (clinicaltrials.gov number: NCT05088356) was conducted to examine the safety and efficacy of Orca-T in participants receiving RIC-alloHCT. Participants have also been treated previously with Orca-T during an ongoing phase 1b/3 study (NCT05316701 and NCT04013685) in participants receiving a MAC regimen. The results of these studies have prompted Orca Bio to further evaluate Orca-T in participants receiving RIC or NMA.

Conditions

• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Mixed Phenotype Acute Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Orca-T	An allogeneic stem cell and T-cell immunotherapy biologic

Timeline

• Start date: 2025-12-09
• Primary completion: 2027-11-01
• Completion: 2028-12-01
• First posted: 2025-10-14
• Last updated: 2026-04-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study