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Exploratory Study of LM103 Injection with TIL Transfer for Advanced Solid Tumors Including Melanoma, Lung, and Cervical Cancer
Led by Suzhou BlueHorse Therapeutics Co., Ltd. · Updated on 2022-08-02
15
Participants Needed
1
Research Sites
260 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, antitumor activity, and immune response of LM103 Injection in patients with advanced solid tumors, including melanoma, non-small cell lung cancer, and cervical cancer. This open-label, single-arm exploratory study aims to assess how well this treatment works and how safe it is for patients whose existing treatments are ineffective or unavailable. The treatment involves harvesting tumor-infiltrating lymphocytes TILs from the patients tumor sample, expanding them ex vivo, and then transferring them back to the patient intravenously after chemotherapy with cyclophosphamide and fludarabine. LM103 Injection is given as a single dose on day 1, combined with interleukin-2 IL-2 therapy to support immune response. The study plans to enroll between 9 and 15 patients. Participants will undergo laboratory tests, imaging, and physical assessments to monitor response and safety for up to two years. Researchers will track adverse events for one year and evaluate tumor response, disease control, progression-free survival, and changes in immune activity. The total study duration includes treatment, follow-up, and monitoring to better understand the effects of LM103 Injection in advanced solid tumors.
CONDITIONS
Brief Title
A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors
Research Team
X
Xu Wen
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