Clinical Trials/NCT06326736

NCT06326736

Recruiting

Early Phase 1

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

Jinling Hospital, China1 site in 1 country12 target enrollmentApril 2024

ConditionsPancreatic Cancer

InterventionsSJ-Neo006 Gemcitabine+Abraxane Surgery Camrelizumab

DrugsCamrelizumab Gemcitabine+Abraxane

Overview

Phase: Early Phase 1
Intervention: SJ-Neo006
Conditions: Pancreatic Cancer
Sponsor: Jinling Hospital, China
Enrollment: 12
Locations: 1
Primary Endpoint: Incidence of Treatment Emergent Adverse Events (TEAEs)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2024

End Date

December 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jinling Hospital, China

Responsible Party

Principal Investigator

Sizhen Wang

associate chief physician

Jinling Hospital, China

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.

Arms & Interventions

Pancreatic Cancer

Resectable primary pancreatic tumor

Intervention: SJ-Neo006

Pancreatic Cancer

Resectable primary pancreatic tumor

Intervention: Gemcitabine+Abraxane

Pancreatic Cancer

Resectable primary pancreatic tumor

Intervention: Surgery

Pancreatic Cancer

Resectable primary pancreatic tumor

Intervention: Camrelizumab

Outcomes

Primary Outcomes

Incidence of Treatment Emergent Adverse Events (TEAEs)

Time Frame: 2 years

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.