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This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM303 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM303 | Experimental | Treatment with LM303 injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM303 | Drug | Treatment with LM303 injection |
|
| 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 | |
|---|---|---|---|---|
| Feng e Li | Contact | 13821072072 | rosetea85@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Beichen Hospital | Recruiting | Tianjin | 300000 | China |
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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 |