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).

Trial Details

NCT ID
NCT07216443
Phase
PHASE2
Sponsor
Orca Biosystems, Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Orca-T
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Tampa, Florida, United States|27.94752,-82.45843
  • Hackensack, New Jersey, United States|40.88593,-74.04347
  • New York, New York, United States|40.71427,-74.00597
  • Portland, Oregon, United States|45.52345,-122.67621

Key Eligibility Criteria

  • Age ≥18 years at the time of enrollment
  • Diagnosed with 1 of the following diseases:
  • Acute myeloid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presenc…
  • Myelodysplastic syndrome that is indicated for alloHCT per the 2017 International Expert Panel recommendations and/or therapy-related/secondary MDS…

For full eligibility, visit ClinicalTrials.gov.

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