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NCT05139056

Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 6 months later.

See at-risk trials from City of Hope Medical Center

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Record History

All 17 versions: 16 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Aug 4, 2027 to Feb 7, 2028
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: details revised at 3 of 9 entries
  2. Recruitment resumed after suspension
    • Site details revised at 4 of 4 sites
    v16
  3. Primary and study completion dates: Aug 7, 2026 to Aug 4, 2027v15
  4. Trial status: Recruiting to Suspended Sponsor's reason: Safety issues
    • Site details revised at 4 of 4 sites
    v14
  5. Site details revised at 1 of 4 sitesv13
Show 10 earlier versionsHide 10 earlier versions
  1. Primary endpoints: 1 to 2v12 Show 6 more changesShow less
    • Primary and study completion dates: Dec 7, 2026 to Aug 7, 2026
    • Eligibility criteria shortened, about 69 words
    • Secondary endpoints revised (9)
    • Study description expanded, about 118 words
    • Site contacts updated at 3 of 4 sites
    • Study title expanded, about 1 word
  2. Primary and study completion dates: Aug 7, 2025 to Dec 7, 2026v11
  3. Study sites: 1 to 4v9
  4. Primary and study completion dates: Dec 20, 2023 to Aug 7, 2025v8
  5. Start date changed from estimate of May 15, 2023 to May 2, 2023v7
  6. Trial status: Withdrawn to Recruiting
    • Start date: Jan 15, 2023 to May 15, 2023
    • Enrollment target: 0 to 36
    • Study sites: 0 to 1
    v6
  7. Trial status: Not Yet Recruiting to Withdrawn Sponsor's reason: Slow/Low accrual
    • Enrollment target: estimated 30 to confirmed 0
    • Start date: Oct 15, 2022 to Jan 15, 2023
    • Study sites: 1 to 0
    v5
  8. Start date: Jul 15, 2022 to Oct 15, 2022v4
  9. Start date: Apr 15, 2022 to Jul 15, 2022v3
  10. Start date: Dec 17, 2021 to Apr 15, 2022
    • Primary and study completion dates: Jun 30, 2023 to Dec 20, 2023
    v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of adverse events
Timeframe: Up to 30 days post removal of Rickhams
Progression-free survival (PFS)
Timeframe: From the time of surgery to the event date of progression, assessed at 6 months]

Secondary (9)

Neural Stem Cells-expressing CRAd-S-pk7 (NSC-CRAd-S-pk7) immunogenicity
NSC-CRAd-S-pk7 migration within the brain
NSC-CRAd-S-pk7 migration outside the brain
Disease response
Overall survival (OS)
Show 4 moreShow less
Changes in HSPG and survivin expression
Changes in immune cell populations
Changes in tumor growth
Assessed using multiplex immunoassays in cerebrospinal fluid (CSF) samples and RNA-sequencing in CSF, peripheral blood, and tumor tissue samples.

Arms and interventions

Treatment (NSC-CRAd-S-pk7)Experimental

Patients undergo standard surgical resection, and during surgery the first dose of study agent is injected into the wall of the resection cavity. Patients then receive three additional doses every week or every two weeks (depending on when they enroll in the study) via a catheter that was placed during surgery

Biologicals: Neural Stem Cells-expressing CRAd-S-pk7

Procedures: Resection

Sites

4 sites in 1 country