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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 5 to 6v8
  2. Site details revised at 1 of 5 sitesv7
  3. Site details revised at 1 of 5 sitesv6
  4. Study sites: 4 to 5v5
  5. Start date: Dec 12, 2025 to Dec 9, 2025 Site details revised at 2 of 4 sitesv4 Show 1 more changeShow less
    • Site details revised at 2 of 4 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Start date changed from estimate of Nov 2025 to Dec 12, 2025 Secondary endpoints: 15 to 20 · Study description shortened, about 7 words · Eligibility criteria shortened, about 2 words · 1 morev3 Show 4 more changesShow less
    • Secondary endpoints: 15 to 20
    • Study description shortened, about 7 words
    • Eligibility criteria shortened, about 2 words
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Oct 2027 to Nov 2027 Start date: Oct 7, 2025 to Nov 2025v2 Show 1 more changeShow less
    • Start date: Oct 7, 2025 to Nov 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT07216443
Lead Sponsor Orca Biosystems, Inc.
Conditions Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov