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GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Study completion pushed from Jun 30, 2026 to Dec 30, 2026v7
  2. Primary completion date changed from estimate of Aug 31, 2025 to Sep 25, 2025
    • Study completion date: Dec 31, 2025 to Jun 30, 2026
    v6
  3. Primary endpoints: 4 to 6
    • Eligibility criteria shortened, about 12 words
    v5
  4. Primary completion date: Aug 31, 2023 to Aug 31, 2025v4
  5. Study sites: 1 to 5v3
  6. Study title shortened, about 7 wordsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period. The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes： 1. Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine). 2. GT101 infusion. 3. post-infusion treatment (interleukin-2 intravenous push).
Trial Details
NCT Number NCT05430373
Lead Sponsor Grit Biotechnology
Conditions
(from sponsor)		 Solid Tumors, Adult
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov