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Phase 1 Study of Locoregional Injections of Ex Vivo Expanded Natural Killer Cells

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2025 to Mar 4, 2025
    • Site details revised
    v8
  2. Primary completion date: Oct 2024 to Dec 31, 2030v7 Show 9 more changesShow less
    • Start date: Dec 2023 to Apr 1, 2025
    • Primary endpoints revised (2)
    • Enrollment target: 24 to 18
    • Study completion date: Oct 2025 to Oct 2031
    • Eligibility criteria shortened, about 35 words
    • Secondary endpoint revised
    • Study description expanded, about 35 words
    • Site contact updated
    • Study title expanded, about 4 words
  3. Start date: Jul 2022 to Dec 2023v6
  4. Start date: Oct 2021 to Jul 2022v5
  5. Primary completion date: Oct 2023 to Oct 2024
    • Start date: Oct 2020 to Oct 2021
    • Study completion date: Oct 2024 to Oct 2025
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jun 2020 to Oct 2020
    • Primary completion date: Jun 2023 to Oct 2023
    • Study completion date: Jun 2024 to Oct 2024
    v3
  2. Start date: Mar 2020 to Jun 2020
    • Primary completion date: Mar 2023 to Jun 2023
    • Study completion date: Mar 2024 to Jun 2024
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Each patient will receive up to 12 cycles of TGFβi NK cell infusions. Each cycle will be of 4 weeks duration. During the first 3 weeks, TGFβi NK cells will be infused once weekly. The 4th week will be a rest week. TGFβi NK cell infusions should be delivered at least 3 days apart (e.g., Friday of Week 1 and Monday of Week 2). Dose will be escalated in an inter-patient stepwise fashion consisting of 3 dose levels.
Trial Details
NCT Number NCT04254419
Lead Sponsor Nationwide Children's Hospital
Conditions
(from sponsor)		 High Grade Glioma
Related terms Glioma
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov