Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326736
• Other study ID #: 2024NZKY-014-02
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Jinling Hospital, China
• Contact: Xinbo Wang, MD
• Phone: 13505172912
• Email: wxinbo2008[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Surgery
Tumors of patients with pancreatic cancer must be radiographically resectable, and subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation.

Drug:
• Camrelizumab
Camrelizumab will be administered 6 weeks post-tumor resection.

Biological:
• SJ-Neo006
SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks).

Drug:
• Gemcitabine+Abraxane
Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.

Locations

Country	Name	City	State
China	Wang Sizhen	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jinling Hospital, China	Jiangsu Synthgene Biotechnology Co.Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events (TEAEs)	To observe and evaluate the safety of Neoantigen mRNA vaccine combined with Camrelizumab, for the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.	2 years
Secondary	Disease control rate (DCR)	The efficacy of Neoantigen mRNA vaccine combined with Camrelizumab by tumor lesion recurrence cycle at different time.	3,6,12 months