A Phase II Trial of LM103 in Advanced Melanoma

May 9, 2026 updated by: Suzhou BlueHorse Therapeutics Co., Ltd.

A Multicenter, Randomized, Controlled, Open-label, Phase II Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Treatment of Advanced Melanoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jun Guo, Prof. Dr. Med
  • Phone Number: 86-10-88121122
  • Email: guoj307@126.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Go Broad Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The Third People's Hospital of Zhengzhou
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, China
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At the date of signing Informed Consent Form (ICF), 18 ~75 years old, male or female;
  • Expected survival time >3 months;
  • ECOG performance status 0-1;
  • Patients with unresectable recurrent/metastatic melanoma (excluding uveal melanoma) who have failed at least two lines of standard treatment: • Patients need to have failed or be intolerant to PD-1 antibody treatment; • If the BRAF V600 mutation is positive, treatment with BRAF±MEK inhibitors must fail; • If the NRAS mutation is positive, treatment with Tunlametinib must fail;
  • Patients have lesions that can be used for surgical resection or biopsy puncture;
  • Even after tumor tissue resection/biopsy puncture, there should still be at least one measurable lesion (according to RECIST1.1);
  • Patients have sufficient hematology and organ functions;
  • Voluntarily sign a written informed consent form (ICF).

Exclusion Criteria:

  • A history of other malignant tumors within the past 5 years, excluding malignant tumors that can be expected to heal after treatment (including but not limited to well-treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery);
  • Adverse reactions caused by previous treatments have not been recovered to grade ≤1(CTCAE V5.0) (excluding the laboratory tests from the inclusion criteria, alopecia and neurotoxicity, and hypothyroidism, adrenal insufficiency and hypopituitarism that cannot be restored to grade 2 as determined by the investigators for a long time);
  • Any immune-related adverse reaction (irAE) with a severity level greater than grade 3 that has occurred during any previous immunotherapy and has been permanently discontinued;
  • Have received vaccination within two months prior to tumor tissue procurement surgery, or plan to receive vaccination during the study;
  • Have received TIL cell therapy, allogeneic T cell therapy or NK cell therapy within 6 months prior to signing the ICF;
  • Have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
  • Suffering from central nervous system metastases and/or cancerous meningitis. Patients who have received brain metastasis treatment and whose conditions have been stable for at least 6 months, and there is no evidence of new or expanded brain metastases may consider participating in this study;
  • Suffering from or suspected of having an active autoimmune disease;
  • Suffering from a large amount of pleural effusion or ascites with clinical symptoms or requiring symptomatic treatment;
  • Patients with current or previous irreversible interstitial lung disease;
  • Suffering from serious cardiovascular and cerebrovascular diseases;
  • Suffering from an active infection that requires systemic treatment;
  • Suffering from infectious diseases such as hepatitis B, hepatitis C, syphilis, AIDS;
  • Patients with esophageal or gastric varices requiring immediate intervention (such as ligation or sclerotherapy), or those with a higher risk of bleeding as recommended by the investigator or gastroenterologist or hepatologist, evidence of portal hypertension (including splenomegaly found in imaging examinations), or a history of variceal bleeding must undergo endoscopic assessment within 3 months before enrollment;
  • Uncontrolled metabolic disorders, such as diabetes, or other non-malignant organ or systemic diseases or secondary reactions to cancer, can lead to higher medical risks and/or uncertainties in survival assessment;
  • Those who are known to be allergic to any component of the investigational drug and the LM103 product formula;
  • Women who are pregnant or breastfeeding;
  • As determined by the investigators, there are other severe, acute or chronic medical diseases, mental disorders or laboratory abnormalities that may increase the risks related to participation in the study or may interfere with the interpretation of the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LM103 TILs Group
Biological: 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.
Active Comparator: Chemotherapy Group
Chemotherapy regimen selected by investigators
Drug: Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin
The subjects will start treatment with a chemotherapy regimen selected by the investigators, including dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
PFS confirmed by the Independent Review Committee (IRC) according to RECIST 1.1
Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Maximum 24 months
OS and OS rates in 6, 12, 18, 24 months
Maximum 24 months
PFS
Time Frame: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
PFS confirmed by the investigators according to RECIST 1.1
Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Objective Response Rate (ORR)
Time Frame: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
ORR assessed by IRC and investigators according to RECIST 1.1
Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Disease Control Rates (DCR)
Time Frame: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
DCR assessed by IRC and investigators according to RECIST 1.1
Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Duration of Response (DoR)
Time Frame: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
DoR assessed by IRC and investigators according to RECIST 1.1
Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Adverse Events (AEs)
Time Frame: Maximum 24 months
AEs will be recorded and assessed according to CTCAE Version 5.0
Maximum 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou BlueHorse Therapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM103-MM-CT02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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