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This is an exploratory clinical study evaluating the safety, tolerability, immune response and preliminary efficacy of LM103 Injection in combination with PD-1 in patients with advanced solid tumours. The research treatment includes LM103 injection, IL-2 therapy, PD-1 therapy,fludarabine and cyclophosphamide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant Group | Experimental | Treatment includes LM103 injection and PD-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM103 | Biological | Patients were treated with PD-1, cyclophosphamide and fludarabine, LM103 and IL-2 treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year estimate |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year estimate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| fenge L doctor | Contact | 86+13821070272 | rosetea85@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Beichen Hospital | Recruiting | China | Tianjin Municipality | 300000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42109657 | Derived | 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. |
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| 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. |
| 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. | through study completion, an average of 1 year estimate |
| Time to response (TTR) | 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. | 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. | 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. | 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. | through study completion, an average of 1 year estimate |