Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer

NCT06326736 | Recruiting Early Phase 1

• 1 other identifier: 2024NZKY-014-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

mRNA vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Disease control rate (DCR)

  3,6,12 months

Study Arms (1)

Pancreatic Cancer

EXPERIMENTAL

Resectable primary pancreatic tumor

Procedure: Surgery; Drug: Camrelizumab; Biological: SJ-Neo006; Drug: Gemcitabine+Abraxane

Interventions

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.

Also known as: Surgical resection

Pancreatic Cancer

Camrelizumab DRUG

Camrelizumab will be administered 6 weeks post-tumor resection.

Also known as: PD-1 inhibitor

Pancreatic Cancer

SJ-Neo006 BIOLOGICAL

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

Also known as: Neoantigen mRNA Vaccines

Pancreatic Cancer

Gemcitabine+Abraxane DRUG

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

Also known as: chemotherapy

Pancreatic Cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead
• Jiangsu Synthgene Biotechnology Co.Ltd.: collaborator

Study Sites (1)

Wang Sizhen

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Surgical Procedures, Operative; camrelizumab; Immune Checkpoint Inhibitors; Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Therapeutics

Study Officials

• Xinbo Wang, MD

  Jinling Hospital, China

  STUDY DIRECTOR

Central Study Contacts

Xinbo Wang, MD

CONTACT

13505172912; wxinbo2008@163.com

Sizhen Wang, MD

CONTACT

15195900565; wsizhen@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 22, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

CN (1)