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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 Interleukin-2 therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous of LM103 | Experimental | ≥5×10^9 cells (LM103) will be infused i.v. to patients after non-myeloablative lymphodepletion treatment with Cyclophosphamide for Injection and Fludarabine Phosphate for Injection. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiyu Wang | Contact | +86 13831195070 | 327369979@qq.com |
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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 complete response, partial response or stable disease 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 tumor. | 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 |