Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Glioma

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Trial status changed: Suspended → Active, Not Recruiting
    • Publications: details revised at 5 of 5 entries
    • Eligibility criteria expanded, about 5 words
  2. Trial status: Recruiting to Suspended Sponsor's reason: Safety issues
    • Site details revised
    v9
  3. Interventions: N-acetylcysteine amide (NACA) (Dietary Supplement), NSC-CRAd-S-pk7 (Biological) to NSC-CRAd-S-pk7 (Biological)
    • Study description shortened, about 47 words
    • Study arms: 2 to 1
    v8
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 30, 2025 to Jun 27, 2025
    v7
  5. Primary completion date: Apr 15, 2027 to Dec 31, 2029v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Apr 15, 2025 to May 30, 2025v5
  2. Primary completion date: Dec 31, 2025 to Apr 15, 2027
    • Start date: Jun 1, 2024 to Apr 15, 2025
    v4
  3. Start date: Jan 2, 2024 to Jun 1, 2024v3
  4. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Northwestern University
388 trials monitored
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Glioma
1,253 trials monitored
See 90 trials at risk
The goal of this clinical trial is to learn about the safety and feasibility of administering repeated doses of neural stem cell (NSC)-conditionally replicative adenovirus (CRAd)-survivin (S)-protomer (p)k7, in persons with newly diagnosed high grade glioma. The main questions it aims to answer are: * whether multiple doses of NSC-CRAd-S-pk7 are safe and feasible * how multiple doses of NSC-CRAd-S-pk7 influence tumor response, overall survival, time to tumor progression, and quality of life. Participants will: * undergo a biopsy to confirm high grade glioma, then receive the first dose of NSC-CRAd-S-pk7 into the brain * about 2 weeks later, undergo surgery to remove the tumor and receive the second dose of NSC-CRAd-S-pk7 into the brain * start chemoradiation about 2 weeks after surgery, then about 2 weeks later, receive the 3rd dose of NSC-CRAd-S-pk7 into the brain * four weeks later, at the end of chemoradiation, receive a fourth dose of NSC-CRAd-S-pk7 into the brain. * after radiation is finished, receive standard of care chemotherapy and tumor-treating fields. Two additional doses of NSC-CRAd-S-pk7 will be given every 4 weeks.
Trial Details
NCT Number NCT06169280
Lead Sponsor Northwestern University
Conditions
(from sponsor)		 Glioma, Malignant, New Diagnosis Tumor
Related terms Glioma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov