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| Name | Class |
|---|---|
| Shanghai Regenelead Therapies Co., Ltd. | INDUSTRY |
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Brief Summary: This study is an open, prospective, exploratory clinical trial designed to evaluate the safety,ability, immunogenicity, and preliminary efficacy of a personalized neoantigen mRNA vaccine in combination with adebelimab as adjuvant treatment for patients with non-small cell lung cancer (NSCLC).
The primary objectives of this study are to answer the following key questions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Safe run-in phase and Dose Expansion phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA Neoantigen Vaccine | Drug | mRNA Neoantigen Vaccine |
| |
| Adebrelimab |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability | Percentage of subjects who meet the criteria of DLT in DLT observation period | From the start of study treatments until 30 days after last dose of study treatments. |
| MTD or MAD | Determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended expansion dose (RDE) of mRNA Neoantigen in combination with adebelimab in the adjuvant treatment of resectable NSCLC after surgery | From the start of study treatments until the end of the safety run-in phase, about 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| immunogenicity | Change in immunogenicity compared to baseline, rate of the immune response | From the sugery til the end of study treatment,about 18 months. |
| Preliminary efficacy | DFS rate and OS rate at 18 months/24 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510000 | China |
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| Drug |
Adebrelimab is a programmed death-ligand 1 antibody. |
|
| 3years |