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RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)

Study acronym: ASPIRE
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Enrollment closed, study ongoing Site details revised Show 1 more changeShow less
    • Site details revised
  2. Minor Eligibility criteria expanded, about 45 words Publications: details revised at 1 of 1 entry Show 1 more changeShow less
    • Publications: details revised at 1 of 1 entry
  3. Notable Trial status changed: Active, Not Recruiting → Recruiting Site details revisedv13 Show 1 more changeShow less
    • Site details revised
  4. Minor Eligibility criteria expanded, about 8 wordsv12 See this version in full on ClinicalTrials.gov ↗
  5. Minor Trial status: Recruiting to Active, Not Recruiting Site details revisedv11 Show 1 more changeShow less
    • Site details revised
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Eligibility criteria shortened, about 8 words Study description shortened, about 31 words · Study arms: 2 to 1v10 Show 2 more changesShow less
    • Study description shortened, about 31 words
    • Study arms: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Site contact updatedv9
  3. Notable Trial status: Active, Not Recruiting to Recruiting Site details revisedv8 Show 1 more changeShow less
    • Site details revised
  4. Notable Primary completion date: Dec 1, 2027 to Dec 1, 2026 Completion date: Dec 1, 2028 to Dec 1, 2027v7 Show 1 more changeShow less
    • Completion date: Dec 1, 2028 to Dec 1, 2027
  5. Notable Start date: Oct 29, 2024 to Dec 2, 2024 Primary completion date: Dec 2027 to Dec 1, 2027 · Completion date: Dec 2028 to Dec 1, 2028v6 Show 2 more changesShow less
    • Primary completion date: Dec 2027 to Dec 1, 2027
    • Completion date: Dec 2028 to Dec 1, 2028
  6. Minor Trial status: Recruiting to Active, Not Recruiting Site details revisedv5 Show 1 more changeShow less
    • Site details revised
  7. Minor Re-verified, no change to tracked fieldsv4
  8. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2024 to Oct 29, 2024 · Eligibility criteria expanded, about 19 words · Study description expanded, about 141 words · 1 morev3 Show 4 more changesShow less
    • Start date changed from estimate of Dec 2024 to Oct 29, 2024
    • Eligibility criteria expanded, about 19 words
    • Study description expanded, about 141 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  9. Minor Collaborators expanded, about 4 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Minor 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 is a Phase I study to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in adult patients with recurrent glioblastoma.
Trial Details
NCT Number NCT06389591
Lead Sponsor University of Florida
Collaborators: National Cancer Institute (NCI)
Conditions Recurrent Glioblastoma
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov