An Exploratory Clinical Study of Safety and Efficacy of Neoantigen mRNA Vaccines in the Treatment of Patients With Resectable Pancreatic Cancer

2024NZKY-014-02

The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines.

2024-04-01

2025-12-01

2026-12-01

Recruiting

Early phase I

12

Inclusion Criteria: * Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF). * Subjects must be \>/= 18 years of age at time of informed consent. * Subjective with radiographically resectable primary pancreatic tumors with radiographic features consistent with adenocarcinoma will be evaluated for surgical resection. * Subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation. * Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG). * Subjects must not have had prior chemotherapy, radiation therapy, or immunotherapy for Pancreatic ductal adenocarcinoma（PDAC）. * Subjects with estimated survival \> 12 weeks. Exclusion Criteria: * Prior neoadjuvant treatment, radiation therapy, anti-PD-1 antibody or any other immune therapy for pancreatic ductal adenocarcinoma. * Known hypersensitivity or allergy to the active substance or to any of the excipients of SJ-neo006, Camrelizumab, Gemcitabine, Abraxane. * Actie, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment. * Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection or subjects receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications. * Pregnancy, breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of study treatment. * New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysthythmia, or electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder. * History or autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease. * Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2024-03-22