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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous tumor infiltrating lymphocytes (TILs) | Experimental | In vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous tumor infiltrating lymphocytes (TILs) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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;
The expected survival time is more than 3 months;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Wen | Contact | 13260921233 | zhuce@lanmabio.com |
| Name | Affiliation | Role |
|---|---|---|
| Fenge Le, Ph.D | Tianjin Beichen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Beichen Hospital | Recruiting | Tianjin | 300000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38222312 | Derived | Li 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. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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|
| 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: | Up to 2 years |
| Progression-Free Survival (PFS) | The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1 | 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 | Up to 2 years |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |