Clinical Study of HS-IT101 Injection in the Treatment of Advanced Renal Cancer(FASTIL-Renal01)

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 9 months later Oct 2026 → Aug 2028
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Hangzhou Huasai Biomedicine Co., Ltd.

Record History

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  1. Study title revised
  2. Primary completion pushed from Oct 2026 to Aug 2028 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Sponsor changed: Qingdao Sino-Cell Biomedicine Co., Ltd. to Hangzhou Huasai Biomedicine Co., Ltd.
    • Recruitment opened
    • Study completion pushed from Aug 2027 to Aug 2028
    • Start date changed from estimate of Oct 2026 to Aug 23, 2026
    • Eligibility criteria expanded, about 210 words
    • Secondary endpoints expanded, about 51 words
  3. 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.
A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Renal Cancer.
Trial Details
NCT Number NCT07770802
Lead Sponsor Hangzhou Huasai Biomedicine Co., Ltd.
Conditions
(from sponsor)		 Clear Cell Renal Cell Carcinoma
Related terms Carcinoma, Renal Cell
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov