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Immune cell army takes on advanced melanoma in new trial

NCT ID NCT07310784

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This phase 2 trial tests a new treatment called LM103 TILs, made from a patient's own immune cells, for advanced melanoma that hasn't responded to standard therapies. About 92 adults will be randomly assigned to receive either the TIL therapy or standard care. The study aims to see if this approach can slow cancer growth and improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, China

  • Beijing Go Broad Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi, China

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, Jilin, China

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Sun Yat-Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi’an, Shanxi, China

  • The Third People's Hospital of Zhengzhou

    RECRUITING

    Zhengzhou, Henan, China

  • The first hospital of Jilin University

    RECRUITING

    Changchun, Jilin, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.