HS-IT101 Injection in the Treatment of Advanced Melanoma(FASTIL-Mela01)

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Lead sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd. to Hangzhou Huasai Biomedicine Co., Ltd. Show 6 more changesShow less
    • Trial status changed: Enrolling by Invitation → Completed
    • Final enrollment: 5 participants (planned 10)
    • Primary completion date changed from estimate of May 30, 2026 to Feb 20, 2026
    • Study completion date changed from estimate of May 30, 2027 to Oct 1, 2026
    • Eligibility criteria expanded, about 34 words
    • Study title revised
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Jun 10, 2025 to Jul 10, 2025
    • Site contact updated
    v3
  3. Eligibility criteria shortened, about 28 words
    • Secondary endpoints: 2 to 1
    v2
  4. Study First Submitted
  • 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.
Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced melanoma.
Trial Details
NCT Number NCT06941818
Lead Sponsor Hangzhou Huasai Biomedicine Co., Ltd.
Conditions
(from sponsor)		 Advanced Melanoma
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov