Actively Recruiting
A Multicenter, Randomized, Controlled, Open-label Phase II Trial of LM103 Tumor Infiltrating Lymphocyte Injection for Advanced Melanoma
Led by Suzhou BlueHorse Therapeutics Co., Ltd. · Updated on 2026-05-12
92
Participants Needed
13
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating LM103 tumor infiltrating lymphocyte (TIL) injection therapy compared to chemotherapy for adults with advanced melanoma who have not responded to at least two prior standard treatments. This phase II trial aims to assess the effects of these treatments on progression-free survival and other outcomes over a 24-month follow-up period. The study involves a total of 92 participants randomly assigned to either the LM103 TILs group or a chemotherapy group. The experimental treatment involves extracting, growing, and expanding TILs from the patient's tumor tissue, followed by a non-myeloablative lymphodepletion (NMA-LD), infusion of LM103 TILs, and supportive interleukin-2 treatment. The comparison group receives chemotherapy regimens selected by investigators, including drugs like dacarbazine, temozolomide, paclitaxel, and platinum-based agents. Both groups receive treatment according to their assigned arm, with monitoring scheduled throughout the study. Participants will be monitored regularly with assessments every 6 weeks in the first 6 months and every 12 weeks thereafter up to 24 months. These assessments include measuring progression-free survival, overall survival, response rates, disease control, duration of response, and monitoring adverse events. The study involves clinical evaluations, imaging to track tumor lesions, and laboratory tests to ensure safety and effectiveness of the treatments.
CONDITIONS
Brief Title
A Phase II Trial of LM103 in Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at time of consent
- Expected survival time greater than 3 months
- ECOG performance status of 0 or 1
- Diagnosed with unresectable recurrent or metastatic melanoma (excluding uveal melanoma) that has failed at least two standard treatments
- Failed or intolerant to PD-1 antibody treatment
- If positive for BRAF V600 mutation, failed treatment with BRAFMEK inhibitors
- If positive for NRAS mutation, failed treatment with Tunlametinib
- Have lesions suitable for surgical removal or biopsy
- Have at least one measurable lesion after tumor tissue removal
- Adequate blood and organ function
- Voluntarily signed informed consent form
You will not qualify if you...
- History of other malignant tumors within past 5 years, except certain treated cancers expected to be cured
- Unresolved adverse reactions from previous treatments worse than grade 1 (with some exceptions)
- Prior immune-related adverse events greater than grade 3 leading to permanent discontinuation
- Vaccination within 2 months before tumor tissue surgery or planned vaccination during study
- Prior TIL cell therapy, allogeneic T cell therapy, or NK cell therapy within 6 months
- History of allogeneic stem cell or solid organ transplantation
- Current central nervous system metastases or cancerous meningitis, except stable brain metastases treated and stable for 6 months
- Active or suspected autoimmune diseases
- Large symptomatic pleural effusion or ascites needing treatment
- Irreversible interstitial lung disease
- Serious cardiovascular or cerebrovascular diseases
- Active infections requiring systemic treatment
- Infectious diseases such as hepatitis B, C, syphilis, or AIDS
- Esophageal or gastric varices needing immediate intervention or high bleeding risk
- Uncontrolled metabolic or systemic diseases increasing medical risks
- Known allergy to any components of the study drug or LM103 formulation
- Pregnant or breastfeeding women
- Other severe medical or mental disorders increasing study risk or interfering with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of active treatment as determined by the study protocol
Participants receive either LM103 tumor infiltrating lymphocyte injection following non-myeloablative lymphodepleting chemotherapy and IL-2 supportive treatment, or a chemotherapy regimen selected by investigators.
Regular visits for treatment and assessments during active therapy
Duration - Up to 24 months
Participants are monitored for progression-free survival, overall survival, response rates, and adverse events after completing treatment.
Visits every 6 weeks for the first 6 months, then every 12 weeks up to 24 months
Trial Site Locations
Total: 13 locations
1
Beijing Go Broad Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
3
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
4
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
5
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Actively Recruiting
6
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Actively Recruiting
7
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
8
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
9
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Actively Recruiting
10
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
11
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
12
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
13
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
J
Jun Guo, Prof. Dr. Med
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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