Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
92 participants
INTERVENTIONAL
2025-12-16
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LM103 TILs Group
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.
Chemotherapy Group
Chemotherapy regimen selected by investigators
Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin
The subjects will start treatment with a chemotherapy regimen selected by the investigators, including dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin.
Interventions
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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.
Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin
The subjects will start treatment with a chemotherapy regimen selected by the investigators, including dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Suzhou BlueHorse Therapeutics Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Jun Guo
Role: primary
Other Identifiers
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LM103-MM-CT02
Identifier Type: -
Identifier Source: org_study_id