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NCT Number: NCT06326736

Study of Neoantigen mRNA Vaccines in 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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Wang Sizhen

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

wu qiong

CONTACT

02580863234

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery

Procedure

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

Camrelizumab

Drug

Camrelizumab will be administered 6 weeks post-tumor resection.

Other names: PD-1 inhibitor

SJ-Neo006

Biological

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

Other names: Neoantigen mRNA Vaccines

Gemcitabine+Abraxane

Drug

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

Other names: chemotherapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sizhen Wang, MD

CONTACT

[email protected]

15195900565

Xinbo Wang, MD

CONTACT

[email protected]

13505172912

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Collaborators

  • Jiangsu Synthgene Biotechnology Co.Ltd.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 22, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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