Advanced MelanomaPhase 2NCT07310784
A Phase II Trial of LM103 in Advanced Melanoma
A Phase 2 study testing LM103 TILs Injection and Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin in people with Advanced Melanoma, run by Suzhou BlueHorse Therapeutics Co., Ltd. at 16 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- LM103 TILs Injection and Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 16 sitesChina
- Study dates
- 16 Dec 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Beijing Go Broad Hospital
Beijing, Beijing Municipality
Chuanliang Cui, +8613691489319, 1008ccl@163.com
- Recruiting
Beijing Cancer Hospital
Beijing
Jun Guo, +861088121122, guoj307@126.com
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin
Xueying Zhang, +8613304329877, 554597526@qq.com
- Recruiting
The first hospital of Jilin University
Changchun, Jilin
Di Wu, +8615104487510, wudi888991@163.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Yu Jiang, +8618980601130, jiangyuwork@126.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Yu Chen, +8613859089836, 13859089836@139.com
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong
Xiaoshi Zhang, +8615915733209, zhangxsh@sysucc.org.cn
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Meiyu Fang, +8613750851650, fangmy@zjcc.org.cn
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Zhengyun Zou, +8613815891858, zouzhengyun001@163.com
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
Zhenchao Yuan, +8618677102309, yzhenchao11@163.com
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Jie Ma, +8613978851892, majie086@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhiguo Luo, +8618017312688, luozhiguo@aliyun.com
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Xiubao Ren, +8618622221235, renxiubao@tjmuch.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Jing Chen, +8615807183251, bswhunion@163.com
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Yinbin Zhang, +8615334213430, 23227119@qq.com
- Recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan
Xianbin Liang, +8615038212930, wslxb666@126.com
About this study
Official title: A Multicenter, Randomized, Controlled, Open-label, Phase II Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Treatment of Advanced Melanoma
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
- Being tested
- LM103 TILs Injection, Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM103 TILs InjectionBiological
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/cisplatinDrug
The subjects will start treatment with a chemotherapy regimen selected by the investigators, including dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin.
| Study group | Role | What they receive |
|---|---|---|
| LM103 TILs Group | Experimental | Not described Receives: Biological: LM103 TILs Injection |
| Chemotherapy Group | Active comparator | Chemotherapy regimen selected by investigators Receives: Drug: Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS confirmed by the Independent Review Committee (IRC) according to RECIST 1.1
Measured: 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)
OS and OS rates in 6, 12, 18, 24 months
Measured: Maximum 24 months
PFS
PFS confirmed by the investigators according to RECIST 1.1
Measured: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Objective Response Rate (ORR)
ORR assessed by IRC and investigators according to RECIST 1.1
Measured: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Disease Control Rates (DCR)
DCR assessed by IRC and investigators according to RECIST 1.1
Measured: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Duration of Response (DoR)
DoR assessed by IRC and investigators according to RECIST 1.1
Measured: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Adverse Events (AEs)
AEs will be recorded and assessed according to CTCAE Version 5.0
Measured: Maximum 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start16 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou BlueHorse Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310784
- Sponsor's protocol ID
- LM103-MM-CT02
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Open-label, Phase II Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Treatment of Advanced Melanoma
- ClinicalTrials.gov ID
- NCT07310784
- Acronym / sponsor ID
- LM103-MM-CT02
- Conditions
- Advanced Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Suzhou BlueHorse Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LM103 TILs Group | Experimental | Biological: LM103 TILs Injection |
| Chemotherapy Group | Active comparator | Drug: Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatinChemotherapy regimen selected by investigators |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LM103 TILs InjectionExtract, 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. | Biological | LM103 TILs Group |
| Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatinThe subjects will start treatment with a chemotherapy regimen selected by the investigators, including dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin. | Drug | Chemotherapy Group |
Primary outcome
Progression-free survival (PFS)
Time frame: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
PFS confirmed by the Independent Review Committee (IRC) according to RECIST 1.1
6 secondary outcomes
Overall survival (OS)
Time frame: Maximum 24 months
PFS
Time frame: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Objective Response Rate (ORR)
Time frame: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Disease Control Rates (DCR)
Time frame: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Duration of Response (DoR)
Time frame: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
Adverse Events (AEs)
Time frame: Maximum 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LM103 TILs Injection and Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin in people with Advanced Melanoma, run by Suzhou BlueHorse Therapeutics Co., Ltd. at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Guo, Prof. Dr. Med (86-10-88121122, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.