Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer

March 17, 2024 updated by: Sizhen Wang, Jinling Hospital, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Wang Sizhen
        • Contact:
          • wu qiong
          • Phone Number: 02580863234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pancreatic Cancer
Resectable primary pancreatic tumor
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.
Other Names:
  • Surgical resection
Drug: Camrelizumab
Camrelizumab will be administered 6 weeks post-tumor resection.
Other Names:
  • PD-1 inhibitor
Biological: SJ-Neo006
SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks).
Other Names:
  • Neoantigen mRNA Vaccines
Drug: Gemcitabine+Abraxane
Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.
Other Names:
  • chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: 3,6,12 months
The efficacy of Neoantigen mRNA vaccine combined with Camrelizumab by tumor lesion recurrence cycle at different time.
3,6,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Collaborators

Jiangsu Synthgene Biotechnology Co.Ltd.

Investigators

  • Study Director: Xinbo Wang, MD, Jinling Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 17, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024NZKY-014-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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