Clinical trial NCT06326736: Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer
Official title: An Exploratory Clinical Study of Safety and Efficacy of Neoantigen mRNA Vaccines in the Treatment of Patients With Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Pancreatic Cancer
Keywords: mRNA vaccine
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: Jiangsu Synthgene Biotechnology Co.Ltd.
First posted: 2024-03-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The first purpose of this study is to evaluate the safety of treating pancreatic cancer with surgery to remove cancerour tissue.

Following with camrelizumab and a personalized Neoantigen mRNA Vaccines, and then with chemotherapy.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: 2 years
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: 3,6,12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Wang Sizhen
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Xinbo Wang, MD
role: STUDY_DIRECTOR
References: