HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma（FASTIL-Mela02）

This is a multicenter, randomized controlled, open-label Phase II clinical study designed to evaluate the efficacy and safety of HS-IT101 Injection versus the investigator's choice of chemotherapy in participants with advanced melanoma. A total of 90 participants are planned to be enrolled, and eligible participants will be randomly assigned to the experimental group or control group at a 1:1 ratio. The experimental group will receive a single administration of autologous tumor-infiltrating lymphocyte therapy, while the control group will receive chemotherapy regimens selected by the research

Trial Details

NCT ID
NCT07406724
Phase
PHASE2
Sponsor
Hangzhou Huasai Biomedicine Co., Ltd.
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Tumor Tissue Sampling
  • Lymphodepletion Conditioning
  • Infusion of HS-IT101 Injection
  • IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy
  • Investigator's selection of appropriate chemotherapy regimen
Locations (sample)
  • Beijing, China|39.9075,116.39723

Key Eligibility Criteria

  • Participants aged 18 to 75 years, inclusive.
  • Patients with cytologically or histologically confirmed unresectable advanced, recurrent, or metastatic melanoma (excluding uveal melanoma), who ha…
  • Disease Progression Following Anti-PD-1 Therapy.
  • At least one tumor lesion not treated with radiotherapy or other local therapies within 28 days prior to resection, suitable for autologous tumor-i…

For full eligibility, visit ClinicalTrials.gov.

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