MelanomaPhase 1NCT05366478
A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors
A Phase 1 study testing Autologous tumor infiltrating lymphocytes (TILs) in people with Melanoma and Non Small Cell Lung Cancer, run by Suzhou BlueHorse Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM103 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Non Small Cell Lung Cancer, Cervical Carcinoma
- What is being tested?
- Autologous tumor infiltrating lymphocytes (TILs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2022to 30 May 2029
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment;
- The patient has residual lesions that can be used for surgical resection (>1.5cm3) or biopsy (>1.5cm3) and measurable after resection for TIL collection and efficacy evaluation;
- Laboratory inspection index requirements:
- Blood routine: lymphocyte ratio > 20%; neutrophil count > 1.0 × 10^9/L; white blood cells > 3.0 × 10^9/L; platelets > 100 × 10^9/L; hemoglobin > 80 g/ L;
- Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ upper limit of normal x 2.5, if there is liver metastasis ≤ upper limit of normal x 5; alkaline phosphatase (ALP) ≤ upper limit of normal x 2.5; total gallbladder Red pigment (TBIL)≤normal upper limit×1.5;
- Renal function: urea ≤ upper limit of normal × 1.5; creatinine (Cr) ≤ upper limit of normal × 1.5;
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- Left ventricular ejection fraction (LVEF) ≥ 50%;
- ECOG physical condition is 0 or 1;
- The expected survival time is more than 3 months;
Who cannot join
- Suffering from active or previous autoimmune diseases ;
- Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;
- Combined with severe infection or persistent infection and cannot be effectively controlled;
- Central nervous system metastasis and/or cancerous meningitis;
- With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- Requires systemic steroid therapy;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb); positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Beichen Hospital
Tianjin, 300000
Li Feng'e, 13821072072, rosetea85@163.com
About this study
Official title: A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors
This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM103 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.
Read the detailed description
This is an investigator initiated , single-arm, open-label ,exploratory study of LM103 Injection in patients with advanced solid tumors. Expanded TILs will be transferred to the patient after chemotherapy with cyclophosphamide and fludarabine. LM103 will be administered as a single dose on day 1. TIL transfer will be combined with IL-2 treatment. This study is planned to enroll 9-15 patients with advanced solid tumors.
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Cervical Carcinoma
- Being tested
- Autologous tumor infiltrating lymphocytes (TILs)
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous tumor infiltrating lymphocytes (TILs)Drug
Also called LM103
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients will be infused with LM103 Injection followed by IL-2.
| Study group | Role | What they receive |
|---|---|---|
| Autologous tumor infiltrating lymphocytes (TILs) | Experimental | In vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors Receives: Drug: Autologous tumor infiltrating lymphocytes (TILs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: Up to 1 years
Secondary outcomes (4)
Number of Participants With Objective Response
Participants displaying objective response associated with the treatment regimen per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Measured: Up to 2 years
Disease Control Rate (DCR）
Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST v1.1：
Measured: Up to 2 years
Progression-Free Survival (PFS)
The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1
Measured: Up to 2 years
The changes of the immunoreactivity during treatment
The changes from baseline of systemic immune Response markers: peripheral blood lymphocyte subtypes counts, cytokine, antigen-specific T-lymphocytes
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start30 May 2022
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou BlueHorse Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fenge Le, Ph.D, Principal investigator, Tianjin Beichen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366478
- Sponsor's protocol ID
- TIL-2021001
- Status last verified
- Aug 2022
- First submitted
- 5 May 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li F, Yang J, Lizee G, Xue Y, Wang R, Zhang C, Gao X, Zhao X, Liu M, Lu W, Wang Y, Feng W, Ma C, Ma Y. T cell receptor repertoire dynamics and newly identified functional regulators of autologous tumor-infiltrating lymphocyte therapy in advanced solid tumors. J Transl Med. 2026 Aug 11;24(1):1068. doi: 10.1186/s12967-026-08781-z.
PubMed 42618927Li F, Wang Y, Yan J, Wu H, Du X, Feng W, Zhang X, Xue Y, Wang H, Liu W. Autologous Tumor-Infiltrating Lymphocyte Mono-Therapy Can Rapidly Shrank Tumor in Asian Patient with Stage III/IV Cervical Cancer: Two Cases Report. Int J Womens Health. 2024 Jan 9;16:31-39. doi: 10.2147/IJWH.S446768. eCollection 2024.
PubMed 38222312
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05366478
- Acronym / sponsor ID
- TIL-2021001
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Cervical Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Suzhou BlueHorse Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 9 May 2022 (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.
This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM103 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.
Detailed description
This is an investigator initiated , single-arm, open-label ,exploratory study of LM103 Injection in patients with advanced solid tumors. Expanded TILs will be transferred to the patient after chemotherapy with cyclophosphamide and fludarabine. LM103 will be administered as a single dose on day 1. TIL transfer will be combined with IL-2 treatment. This study is planned to enroll 9-15 patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous tumor infiltrating lymphocytes (TILs) | Experimental | Drug: Autologous tumor infiltrating lymphocytes (TILs)In vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment;
- The patient has residual lesions that can be used for surgical resection (>1.5cm3) or biopsy (>1.5cm3) and measurable after resection for TIL collection and efficacy evaluation;
- Laboratory inspection index requirements:
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- ECOG physical condition is 0 or 1;
Key exclusion criteria (7 listed)
- Suffering from active or previous autoimmune diseases ;
- Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;
- Combined with severe infection or persistent infection and cannot be effectively controlled;
- Central nervous system metastasis and/or cancerous meningitis;
- With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
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 |
|---|---|---|
| Autologous tumor infiltrating lymphocytes (TILs)Also: LM103A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients will be infused with LM103 Injection followed by IL-2. | Drug | Autologous tumor infiltrating lymphocytes (TILs) |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Up to 1 years
Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
4 secondary outcomes
Number of Participants With Objective Response
Time frame: Up to 2 years
Disease Control Rate (DCR）
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
The changes of the immunoreactivity during treatment
Time frame: Up to 2 years
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 2 Aug 2022.
- Derived from this study: PubMed 42618927Li F, Yang J, Lizee G, Xue Y, Wang R, Zhang C, Gao X, Zhao X, Liu M, Lu W, Wang Y, Feng W, Ma C, Ma Y. T cell receptor repertoire dynamics and newly identified functional regulators of autologous tumor-infiltrating lymphocyte therapy in advanced solid tumors. J Transl Med. 2026 Aug 11;24(1):1068. doi: 10.1186/s12967-026-08781-z.
- Derived from this study: PubMed 38222312Li F, Wang Y, Yan J, Wu H, Du X, Feng W, Zhang X, Xue Y, Wang H, Liu W. Autologous Tumor-Infiltrating Lymphocyte Mono-Therapy Can Rapidly Shrank Tumor in Asian Patient with Stage III/IV Cervical Cancer: Two Cases Report. Int J Womens Health. 2024 Jan 9;16:31-39. doi: 10.2147/IJWH.S446768. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Fenge Le, Ph.D principal investigator
Tianjin Beichen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous tumor infiltrating lymphocytes (TILs) in people with Melanoma and Non Small Cell Lung Cancer, run by Suzhou BlueHorse Therapeutics Co., Ltd. at 1 site 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 9 inclusion and 7 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 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xu Wen (13260921233, zhuce@lanmabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: Up to 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05366478, which also lists 2 linked publications.
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 2 Aug 2022.