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A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 9 words Secondary endpoints: details revised at 10 of 10 entries · Site details revised at 1 of 12 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 10 of 10 entries
    • Site details revised at 1 of 12 sites
  2. Study sites: 11 to 12v19
  3. Study sites: 9 to 11v18
  4. Study sites: 8 to 9v17
  5. Eligibility criteria expanded, about 82 wordsv16 See this version in full on ClinicalTrials.gov ↗
Show 14 earlier versionsHide 14 earlier versions
  1. Enrollment target: 186 to 300 Primary completion date: Apr 2026 to Dec 2027 · Primary endpoints revised (2) · Completion date: Apr 2028 to Dec 2027 · 4 morev15 Show 7 more changesShow less
    • Primary completion date: Apr 2026 to Dec 2027
    • Primary endpoints revised (2)
    • Completion date: Apr 2028 to Dec 2027
    • Eligibility criteria expanded, about 103 words
    • Secondary endpoints: 13 to 10
    • Site details revised at 1 of 8 sites
    • Study arms: 3 to 6

    See this version in full on ClinicalTrials.gov ↗

  2. Site details revised at 3 of 8 sitesv14
  3. Study title shortened, about 3 wordsv13 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion date: Apr 1, 2024 to Apr 2026 Completion date: Apr 1, 2026 to Apr 2028 · Site details revised at 1 of 8 sites · Eligibility criteria expanded, about 3 wordsv12 Show 3 more changesShow less
    • Completion date: Apr 1, 2026 to Apr 2028
    • Site details revised at 1 of 8 sites
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 113 to 186 Primary completion date: Jul 1, 2022 to Apr 1, 2024 · Completion date: Jul 1, 2022 to Apr 1, 2026 · Site details revised at 1 of 8 sites · 2 morev11 Show 5 more changesShow less
    • Primary completion date: Jul 1, 2022 to Apr 1, 2024
    • Completion date: Jul 1, 2022 to Apr 1, 2026
    • Site details revised at 1 of 8 sites
    • Study title revised
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  6. Phase: Not specified to Phase 1 Primary endpoints revised (2) · Trial status: Available to Recruiting · Enrollment target: 113 · 6 morev10 Show 9 more changesShow less
    • Primary endpoints revised (2)
    • Trial status: Available to Recruiting
    • Enrollment target: 113
    • Primary and study completion dates: Jul 1, 2022
    • Start date: Apr 8, 2019
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 12 to 13
    • Study sites revised (8)
    • Study arms: 0 to 3

    See this version in full on ClinicalTrials.gov ↗

  7. Interventions: OrcaGraft (Biological) to OrcaGraft (Orca-Q) (Biological) Study title revisedv9 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  8. Phase: Phase 1 to Not specified Trial status: Recruiting to Available · Enrollment target: 113 to not stated · Primary and study completion dates: Jul 1, 2022 to not stated · 3 morev8 Show 6 more changesShow less
    • Trial status: Recruiting to Available
    • Enrollment target: 113 to not stated
    • Primary and study completion dates: Jul 1, 2022 to not stated
    • Start date: Apr 8, 2019 to not stated
    • Site details revised at 8 of 8 sites
    • Study arms: 2 to 0
  9. Study sites: 7 to 8v7
  10. Study sites: 3 to 7v6
  11. Study sites: 2 to 3v5
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Apr 1, 2019 to Apr 8, 2019v4 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Apr 1, 2019 to Apr 8, 2019
  13. Start date: Feb 1, 2019 to Apr 1, 2019v3
  14. Secondary endpoints: details revised at 6 of 12 entriesv2
  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 engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.
Trial Details
NCT Number NCT03802695
Lead Sponsor Orca Biosystems, Inc.
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia, Acute Lymphoblastic Leukemia
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov