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

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv20
  2. Enrollment target: estimated 255 to confirmed 155 Eligibility criteria shortened, about 7 wordsv19 Show 1 more changeShow less
    • Eligibility criteria shortened, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jul 26, 2024 to Apr 30, 2025 Completion date: Jul 2026 to Apr 2027v18 Show 1 more changeShow less
    • Completion date: Jul 2026 to Apr 2027
  4. Re-verified, no change to tracked fieldsv17
  5. Primary completion date changed from estimate of Jul 2024 to Jul 26, 2024v16
Show 14 earlier versionsHide 14 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Study sites: 22 to 21v15 Show 1 more changeShow less
    • Study sites: 22 to 21
  2. Primary endpoints: 1 to 2 Primary completion date: Apr 30, 2024 to Jul 2024 · Completion date: Apr 30, 2028 to Jul 2026 · Interventions: Orca-T (formerly TregGraft) (Biological) to Orca-T (Biological) · 4 morev14 Show 7 more changesShow less
    • Primary completion date: Apr 30, 2024 to Jul 2024
    • Completion date: Apr 30, 2028 to Jul 2026
    • Interventions: Orca-T (formerly TregGraft) (Biological) to Orca-T (Biological)
    • Eligibility criteria expanded, about 72 words
    • Secondary endpoints revised (5)
    • Site details revised at 1 of 22 sites
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 20 to 22v13
  4. Study sites: 18 to 20v12
  5. Study sites: 17 to 18v11
  6. Study sites: 16 to 17v10
  7. Enrollment target: 84 to 255 Primary completion date: Sep 30, 2022 to Apr 30, 2024 · Study sites: 14 to 16 · Completion date: Nov 30, 2022 to Apr 30, 2028 · 3 morev9 Show 6 more changesShow less
    • Primary completion date: Sep 30, 2022 to Apr 30, 2024
    • Study sites: 14 to 16
    • Completion date: Nov 30, 2022 to Apr 30, 2028
    • Interventions: TregGraft (Orca-T) (Biological) to Orca-T (formerly TregGraft) (Biological)
    • Eligibility criteria expanded, about 89 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 7 to 14 Eligibility criteria expanded, about 6 wordsv8 Show 1 more changeShow less
    • Eligibility criteria expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 6 to 7v7
  10. Primary endpoint revised Interventions: TregGraft (Biological) to TregGraft (Orca-T) (Biological) · Study title revisedv6 Show 2 more changesShow less
    • Interventions: TregGraft (Biological) to TregGraft (Orca-T) (Biological)
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 4 to 6v5
  12. Primary endpoints: 2 to 1 Study sites: 3 to 4 · Secondary endpoints: 12 to 5v4 Show 2 more changesShow less
    • Study sites: 3 to 4
    • Secondary endpoints: 12 to 5

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 1 to 3v3
  14. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Sep 30, 2019 to Nov 21, 2019v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 30, 2019 to Nov 21, 2019
  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.
Trial Details
NCT Number NCT04013685
Lead Sponsor Orca Biosystems, Inc.
Conditions Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Acute Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Myeloid Leukemia
Enrollment 155 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov