Neoantigen mRNA vaccines for resectable pancreatic cancer

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

This study is testing a new personalized vaccine and a medication for people with resectable pancreatic cancer to see if it helps them do better after surgery and chemotherapy.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jinling Hospital, China (other)
• Drugs / interventions: Camrelizumab, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06326736 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a treatment approach for pancreatic cancer that involves surgical removal of cancerous tissue, followed by the administration of camrelizumab and personalized Neoantigen mRNA vaccines. The study aims to create a tailored vaccine for patients with histologically confirmed resected ductal pancreatic adenocarcinoma. Participants will also receive chemotherapy as part of their treatment regimen. The focus is on assessing how well this combination therapy works in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with radiographically resectable primary pancreatic tumors and no prior treatment for pancreatic ductal adenocarcinoma.

Not a fit: Patients who have received prior chemotherapy, radiation therapy, or immunotherapy for pancreatic ductal adenocarcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients with resectable pancreatic cancer.

How similar studies have performed: While the use of mRNA vaccines is a novel approach in this context, similar immunotherapy strategies have shown promise in other cancers, suggesting potential for success.

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.

Where this trial is running

Nanjing, Jiangsu

• Wang Sizhen — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Xinbo Wang, MD

Conditions: Pancreatic Cancer, mRNA vaccine