A Phase II Trial of LM103 in Advanced Melanoma

NCT07310784 | Recruiting Phase 2

• 1 other identifier: LM103-MM-CT02
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Melanoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  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 Outcomes (6)

• Overall survival (OS)

  Maximum 24 months

• PFS

  Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months

• Objective Response Rate (ORR)

  Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months

• Disease Control Rates (DCR)

  Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months

• Duration of Response (DoR)

  Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months

Study Arms (2)

LM103 TILs Group

EXPERIMENTAL

Biological: LM103 TILs Injection

Chemotherapy Group

ACTIVE COMPARATOR

Chemotherapy regimen selected by investigators

Drug: Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin

Interventions

LM103 TILs Injection BIOLOGICAL

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.

LM103 TILs Group

Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin DRUG

The subjects will start treatment with a chemotherapy regimen selected by the investigators, including dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin.

Chemotherapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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 signing the ICF, 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 whose disease progression has been confirmed by imaging examinations within 4 weeks before LM103 reinfusion, 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;

Sponsors & Collaborators

• Suzhou BlueHorse Therapeutics Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Dacarbazine; Temozolomide; Paclitaxel; Carboplatin; Cisplatin

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Jun Guo, Prof. Dr. Med

CONTACT

86-10-88121122; guoj307@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CN (1)