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A Phase II Trial of LM103 in Advanced Melanoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Phase II Trial of LM103 in Advanced Melanoma

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

NCT07310784•Suzhou BlueHorse Therapeutics Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 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;
+8 more criteria

Locations (1)

Beijing Cancer Hospital

Beijing, China

Key Dates

Start Date

December 16, 2025

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2028

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Melanoma

Interventions

LM103 TILs Injection

BIOLOGICAL

Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin

DRUG

Contacts

Jun Guo, Prof. Dr. Med

CONTACT

86-10-88121122 guoj307@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase II Trial of LM103 in Advanced Melanoma

Inclusion Criteria

Exclusion Criteria

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