Immune cell army takes on advanced melanoma in new trial
NCT ID NCT07310784
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced melanoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
16 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGBeijing, China
-
Beijing Go Broad Hospital
RECRUITINGBeijing, Beijing Municipality, China
-
Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
-
Fujian Cancer Hospital
RECRUITINGFuzhou, Fujian, China
-
Guangxi Medical University Cancer Hospital
RECRUITINGNanning, Guangxi, China
-
Jilin Cancer Hospital
RECRUITINGChangchun, Jilin, China
-
Nanjing Drum Tower Hospital
RECRUITINGNanjing, Jiangsu, China
-
Sun Yat-Sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, China
-
The First Affiliated Hospital of Guangxi Medical University
RECRUITINGNanning, Guangxi, China
-
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITINGXi’an, Shanxi, China
-
The Third People's Hospital of Zhengzhou
RECRUITINGZhengzhou, Henan, China
-
The first hospital of Jilin University
RECRUITINGChangchun, Jilin, China
-
Tianjin Medical University Cancer Institute & Hospital
RECRUITINGTianjin, Tianjin Municipality, China
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, China
-
West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, China
-
Zhejiang Cancer Hospital
RECRUITINGHangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a PET scan find the best tumor site for harvesting Cancer-Fighting cells?
- Can a DNA vaccine teach the immune system to hunt melanoma?
- Can a new biologic drug shrink advanced melanoma tumors?
- Engineered immune cells take aim at Hard-to-Treat cancers
- Could a diabetes drug boost immunotherapy in advanced melanoma?
- New combo therapy takes on advanced cancers