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Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study Identification, Study Status, Oversight, IPDSharingv5
  2. Primary endpoints: 2 to 1
    • Enrollment target: 64 to 83
    • Eligibility criteria revised
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 31, 2024 to Apr 2, 2024
    • Site details revised at 24 of 24 sites
    v3
  4. Primary endpoints: 1 to 2
    • Secondary endpoints expanded, about 15 words
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.
Trial Details
NCT Number NCT06241781
Lead Sponsor Grit Biotechnology
Conditions
(from sponsor)		 Adult
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov