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A Phase II Trial of LM103 in Advanced Melanoma
Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.
Summary
A total of 92 subjects with advanced melanoma who met the inclusion criteria will be randomly assigned in a 1:1 ratio to the experimental group and the control group in this phase II trial. The study will be followed up until 24 months after treatment.
Official title: A Multicenter, Randomized, Controlled, Open-label, Phase II Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Treatment of Advanced Melanoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2025-12-16
Completion Date
2028-12-31
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
LM103 TILs Injection
Extract, culture and expand tumor-infiltrating lymphocytes from resected tumor tissues in vitro for the manufactur of LM103 TILs injection. After NMA-LD, the subjects received LM103 infusion and followed by IL-2 supportive treatment.
Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin
The subjects will start treatment with a chemotherapy regimen selected by the investigators, including dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin.
Locations (13)
Beijing Go Broad Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, China