Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM103 | Biological | 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng'e LI | Contact | +86 13821072072 | rosetea85@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Beichen Hospital | Recruiting | Tianjin | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 response (TTR) is defined as the time from randomization until the first documented evidence of CR or PR. | 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 |
| Peripheral blood TILs cell survival | Detection using flow cytometry | through study completion, an average of 1 year estimate |
| Lymphocyte subpopulations | CD3+, CD4+, CD8+, CD4+/CD8+.Detection using flow cytometry | through study completion, an average of 1 year estimate |
| Cytokines | IFN- γ、 TGF- β. Detection using flow cytometry | through study completion, an average of 1 year estimate |
| Diversity of Immune repertoire | Sequence and abundance of T Cell Receptor,B Cell Receptor | 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. | 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 | through study completion, an average of 1 year estimate |