Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer
NCT ID: NCT06326736
Last Updated: 2024-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
12 participants
INTERVENTIONAL
2024-04-30
2026-12-31
Brief Summary
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Detailed Description
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Following with camrelizumab and a personalized Neoantigen mRNA Vaccines, and then with chemotherapy.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pancreatic Cancer
Resectable primary pancreatic tumor
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.
Camrelizumab
Camrelizumab will be administered 6 weeks post-tumor resection.
SJ-Neo006
SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks).
Gemcitabine+Abraxane
Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.
Interventions
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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.
Camrelizumab
Camrelizumab will be administered 6 weeks post-tumor resection.
SJ-Neo006
SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks).
Gemcitabine+Abraxane
Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu Synthgene Biotechnology Co.Ltd.
UNKNOWN
Jinling Hospital, China
OTHER
Responsible Party
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Sizhen Wang
associate chief physician
Principal Investigators
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Xinbo Wang, MD
Role: STUDY_DIRECTOR
Jinling Hospital, China
Locations
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Wang Sizhen
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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wu qiong
Role: primary
Other Identifiers
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2024NZKY-014-02
Identifier Type: -
Identifier Source: org_study_id
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