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

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).

Disease Sites:

Leukemia, Myelodysplastic Syndrome

Staging:

Phase II

Age Group:

Adults

Therapies:

Bone Marrow/Stem Cell Transplant, Chemotherapy - cytotoxic, Radiotherapy

Drugs:

Cyclophosphamide, Fludarabine, Orca-T, Thiotepa

Principal Investigator(s):

Dholaria, Bhagirathbhai

Scope:

National

Participating Institutions:

Vanderbilt University

Open Date:

01-05-2026

Trial Type:

Treatment

Protocol ID:

VICCCTT25025

National Clinical Trial ID:

NCT07216443

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

ALL

Accepts Healthy Volunteers?:

false

Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

Eligibility