Clinical Trial on the Safety and Efficacy of Neoantigen Antigen mRNA Tumor Vaccine in the Treatment of Advanced Esophageal Cancer and Non-small Cell Lung Cancer

STZD-1801

A single arm, open-label pilot study is designed to determine the safety, tolerability and effectiveness of personalized mRNA tumor vaccine encoding neoantigen in Patients with advanced esophageal cancer and non-small cell lung cancer

2019-10-18

2024-10-31

2025-12-31

Recruiting

24

Inclusion Criteria: * Aged between 18 and 75 (including both ends), with no gender limit; * The primary lesion was confirmed by histopathology or cytology as esophageal carcinoma (ⅢC (T4bNanyM0, TanyN3M0), and stage Ⅳ) or non-small cell lung cancer (stage ⅢB-Ⅳ). * Patients who have metastatic or locally advanced tumor but failed instandard treatments or not suitable for standard treatments; * According to RECIST (V1.1), the efficacy evaluation criteria for solid tumors, there is at least one measurable lesion. * Participants with Performance Scale (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) PS * Participants must have at least 1 lesion amenable to the mandatory fresh tumor biopsy at study entry * Fertile patients must agree to use a reliable contraceptive methods (hormonal or barrier methods or abstinence) during the trial and for at least 12 weeks after the last treatment; * The subject voluntarily participates and signs ICF (Informed consent forms). Exclusion Criteria: * Any clinical research drugs, anti-cancer monoclonal antibodies, anti-cancer therapeutic vaccines, immunostimulants (such as IL-2) or using previous investigational drugs within 7 days of the first treatment with mRNA-personalized tumor vaccine or carrelizumab. * Patients who have allergies or previous history of biological drug allergy; * Patients who are in pregnant or breast-feeding; * Patients who are expected to survive less than 3 months during the screening period; * Tumor mutation load (TMB) is less than 2.0/Mb or tumor neogenic antigen load (TNB) is less than 0.5/Mb or the number of predicted neoantigen is less than 3; * Patients who underwent major surgery or suffered significant trauma within 4 weeks prior to the enrollment (blood collection), or who are expected to undergo major surgery during the study period; * Patients with symptoms of brain metastases (Patients with stable brain metastases can be included) * Extensive lung metastases from tumors, causing breathing difficulties; * Patients who have tumors close to large blood vessels or nerves; * A history of severe cardiovascular and cerebrovascular diseases, including but not limited to ventricular arrhythmia requiring clinical intervention; Acute coronary syndrome, myocardial infarction, congestive heart failure, stroke or other grade III and above cardiovascular events within 6 months; New York Heart Association (NYHA) cardiac function grade≥Grade II or left ventricular ejection fraction (LVEF) \<50%; Poorly controlled hypertension after standard treatment (systolic blood pressure\> 150 mmHg and diastolic blood pressure\> 90 mmHg); * Patients with active ulcers and gastrointestinal bleeding; * Patients with clinically confirmed autoimmune disease have received systemic treatment in the past 2 years; HIV, HCV positive; HBV-DNA≥1×103 copies/mL (or 2×102 IU/mL); Acute EBV or CMV virus infection; * Patients with previous history of non-infectious pneumonia requiring steroid therapy or acute lung cancer; * Participants with a history of interstitial lung disease; * Patients who have a history of organ transplantation or are waiting for organ transplantation; * Have any uncontrolled active infection; * Immunosuppressed subjects, including those with known immunodeficiency; those who are currently using steroids systemically (except those who are using inhaled steroids recently or currently); * Skin diseases (such as psoriasis) may prevent intradermal vaccines from reaching the target area; * Who have received chemotherapy, biotherapy, radiotherapy, endocrine therapy, targeted therapy and other tumor treatments, or other experimental drug treatments, or surgery (excluding diagnostic biopsy) within 7 days prior to the first administration of mRNA tumor vaccine treatment; * Adverse effects from previous antitumor therapy have not recovered referred to CTCAE (V5.0) rating ≤1 (except hair loss); * The investigator evaluates that the subject is unable or unwilling to comply with the requirements of study protocol.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2023-04-13