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Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Study acronym: Orca-T
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Publications: details revised at 1 of 1 entryv16
  2. Results first posted: Sep 26, 2025 Secondary endpoints: details revised at 3 of 3 entriesv15 Show 1 more changeShow less
    • Secondary endpoints: details revised at 3 of 3 entries
  3. Primary endpoint revised Secondary endpoints revised (3)v14 Show 1 more changeShow less
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  4. Primary endpoint revised Enrollment target: estimated 174 to confirmed 187 · Secondary endpoints revised (3)v13 Show 2 more changesShow less
    • Enrollment target: estimated 174 to confirmed 187
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date changed from estimate of Apr 2025 to Jul 15, 2024 Completion date: Apr 2027 to Jul 2026v12 Show 1 more changeShow less
    • Completion date: Apr 2027 to Jul 2026
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Trial status: Recruiting to Active, Not Recruiting Study sites revised (19)v10 Show 1 more changeShow less
    • Study sites revised (19)

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Apr 2024 to Apr 2025 Completion date: Apr 2028 to Apr 2027 · Secondary endpoints revised (3) · Study title shortened, about 2 wordsv9 Show 3 more changesShow less
    • Completion date: Apr 2028 to Apr 2027
    • Secondary endpoints revised (3)
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 17 to 19v8
  5. Study sites: 15 to 17v7
  6. Study sites: 14 to 15v6
  7. Study sites: 13 to 14v5
  8. Study sites: 14 to 13 Eligibility criteria expanded, about 14 wordsv4 Show 1 more changeShow less
    • Eligibility criteria expanded, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 9 to 14 Start date changed from estimate of Apr 2022 to Jun 21, 2022 · Study title expanded, about 1 wordv3 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2022 to Jun 21, 2022
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  10. Trial status: Not Yet Recruiting to Recruiting Site details revised at 9 of 9 sitesv2 Show 1 more changeShow less
    • Site details revised at 9 of 9 sites
  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, 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.
Trial Details
NCT Number NCT05316701
Lead Sponsor Orca Biosystems, Inc.
Conditions Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, Undifferentiated Leukemia, Myelodysplastic Syndrome, Acute Leukemia, Therapy-Related Myelodysplastic Syndrome
Enrollment 187 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov