Solid TumorEarly Phase 1NCT05941936
A Clinical Study on LM103 for the Treatment of Advanced Solid Tumors
A Early Phase 1 study testing LM103 in people with Solid Tumor, run by Suzhou BlueHorse Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- LM103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 19 May 2023to Feb 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- The expected survival time is not less than 3 months.
- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
- Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, cervical cancer/ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available.
- The patient has lesions that can be used for surgical resection (>1.5 cm3) or biopsy puncture (no less than 6 lesions) for TILs collection.
- At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria).
- Laboratory tests results during the screening period indicate that the subjects have sufficient organ function.
Who cannot join
- Have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated by radical surgery).
- LM103 received systematic Sex therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis>3 weeks before the start of the study were acceptable) within 4 weeks before LM103 infusion; Or received clinical investigational drugs or equipment treatment.
- Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time).
- Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Beichen Hospital
Tianjin, 300000
Feng'e Li, +86 13821072072, rosetea85@163.com
About this study
Official title: An Exploratory Clinical Study Evaluating the Safety, Tolerance, Immune Response, and Initial Efficacy of Autologous Tumor Infiltrating Lymphocytes (TILs) LM103 Injection in Patients With Advanced Solid Tumors
This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients . The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and IL-2 therapy.
- Conditions
- Solid Tumor
- Being tested
- LM103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM103Biological
Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous of LM103 | Experimental | ≥5×10^9 cells (LM103) will be infused i.v. to patients after NMA lymphodepletion treatment with Cyclophosphamide for Injection and Fludarabine Phosphate for Injection. Receives: Biological: LM103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE)
Incidence and severity of AE, SAE and irAE; Abnormal changes in laboratory and other tests with clinical significance.
Measured: through study completion, an average of 1 year estimate
Secondary outcomes (13)
Objective response rate (ORR)
The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1.
Measured: through study completion, an average of 1 year estimate
Duration of response (DOR)
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause.
Measured: through study completion, an average of 1 year estimate
Disease control rate (DCR)
Disease control rate (DCR) was defined as the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST version 1.1.
Measured: through study completion, an average of 1 year estimate
Time to response (TTR)
Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR or PR.
Measured: through study completion, an average of 1 year estimate
Time to disease progression (TTP)
Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to the solid tomor.
Measured: through study completion, an average of 1 year estimate
Progression free survival (PFS)
Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST version 1.1) or death due to any cause.
Measured: through study completion, an average of 1 year estimate
Overall survival (OS)
OS was defined as the time from first dose to date of death from any cause.
Measured: through study completion, an average of 1 year estimate
Peripheral blood TILs cell survival
Detection using flow cytometry
Measured: through study completion, an average of 1 year estimate
Lymphocyte subpopulations
CD3+, CD4+, CD8+, CD4+/CD8+.Detection using flow cytometry
Measured: through study completion, an average of 1 year estimate
Cytokines
IFN- γ、 TGF- β. Detection using flow cytometry
Measured: through study completion, an average of 1 year estimate
Diversity of Immune repertoire
Sequence and abundance of T Cell Receptor,B Cell Receptor
Measured: through study completion, an average of 1 year estimate
Changes in T cell transcriptome
Track the changes in the clonal frequency of infused TILs, study the transcriptomic dynamics of memory-, activation-, effector function-, exhaustion-, and metabolic fitness-assocated genes in the infused TILs, GSEA and pathway analysis.
Measured: through study completion, an average of 1 year estimate
Level of tumor markers
The expression levels of CA50, CA199 and CEA in Melanoma, CA125, SCC and CA199 in cervical cancer/ovarian cancer, CYFRA21-1, SCC and CEA in non-small cell lung cancer, and CEA, TG and SCC in Head and neck cancer
Measured: through study completion, an average of 1 year estimate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start19 May 2023
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT05941936
- Sponsor's protocol ID
- LM103-001
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li F, Xu Y, Wang Y, Mu N, Liu M, Feng W, Xue Y, Wu S, Wang X, Lizee G, Ma C. Multiple autologous tumor-infiltrating lymphocyte (LM103 infusion) therapy combined with immune checkpoint inhibitor induces repeated tumor regression in a patient with aggressive mucosal melanoma: a case report and literature review. Front Oncol. 2026 Apr 23;16:1789442. doi: 10.3389/fonc.2026.1789442. eCollection 2026.
PubMed 42109657
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study Evaluating the Safety, Tolerance, Immune Response, and Initial Efficacy of Autologous Tumor Infiltrating Lymphocytes (TILs) LM103 Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05941936
- Acronym / sponsor ID
- LM103-001
- Conditions
- Solid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Suzhou BlueHorse Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 May 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 12 Jul 2023 (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 study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients . The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and IL-2 therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous of LM103 | Experimental | Biological: LM103≥5×10^9 cells (LM103) will be infused i.v. to patients after NMA lymphodepletion treatment with Cyclophosphamide for Injection and Fludarabine Phosphate for Injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The expected survival time is not less than 3 months.
- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
- Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, cervical cancer/ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available.
- The patient has lesions that can be used for surgical resection (>1.5 cm3) or biopsy puncture (no less than 6 lesions) for TILs collection.
- At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria).
Key exclusion criteria (4 listed)
- Have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated by radical surgery).
- LM103 received systematic Sex therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis>3 weeks before the start of the study were acceptable) within 4 weeks before LM103 infusion; Or received clinical investigational drugs or equipment treatment.
- Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time).
- Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
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 |
|---|---|---|
| LM103Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion. | Biological | Intravenous of LM103 |
Primary outcome
Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE)
Time frame: through study completion, an average of 1 year estimate
Incidence and severity of AE, SAE and irAE; Abnormal changes in laboratory and other tests with clinical significance.
13 secondary outcomes
Objective response rate (ORR)
Time frame: through study completion, an average of 1 year estimate
Duration of response (DOR)
Time frame: through study completion, an average of 1 year estimate
Disease control rate (DCR)
Time frame: through study completion, an average of 1 year estimate
Time to response (TTR)
Time frame: through study completion, an average of 1 year estimate
Time to disease progression (TTP)
Time frame: through study completion, an average of 1 year estimate
Progression free survival (PFS)
Time frame: through study completion, an average of 1 year estimate
Overall survival (OS)
Time frame: through study completion, an average of 1 year estimate
Peripheral blood TILs cell survival
Time frame: through study completion, an average of 1 year estimate
Lymphocyte subpopulations
Time frame: through study completion, an average of 1 year estimate
Cytokines
Time frame: through study completion, an average of 1 year estimate
Diversity of Immune repertoire
Time frame: through study completion, an average of 1 year estimate
Changes in T cell transcriptome
Time frame: through study completion, an average of 1 year estimate
Level of tumor markers
Time frame: through study completion, an average of 1 year estimate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Derived from this study: PubMed 42109657Li F, Xu Y, Wang Y, Mu N, Liu M, Feng W, Xue Y, Wu S, Wang X, Lizee G, Ma C. Multiple autologous tumor-infiltrating lymphocyte (LM103 infusion) therapy combined with immune checkpoint inhibitor induces repeated tumor regression in a patient with aggressive mucosal melanoma: a case report and literature review. Front Oncol. 2026 Apr 23;16:1789442. doi: 10.3389/fonc.2026.1789442. eCollection 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LM103 in people with Solid Tumor, 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Jul 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng'e LI (+86 13821072072, rosetea85@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE) (time frame: through study completion, an average of 1 year estimate). 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 NCT05941936, which also lists 1 linked publication.
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 12 Jul 2023.