Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer

Early Phase 1

Recruiting

• Conditions: Pancreatic Cancer Resectable; Chemotherapy-intolerant
• Interventions: Biological: Personalized tumor preventive vaccines; Biological: Fixed neoantigen tumor vaccine; Biological: personalized neoantigen tumor vaccine; Drug: PD-1 inhibitor

• Registration Number: NCT06496373
• Lead Sponsor: Ruijin Hospital

Brief Summary

This study primarily aims to assess the safety and tolerability of XP-004 personalized mRNA vaccines encoding tumor neoantigens combined with PD-1 inhibitor as adjuvant therapy for chemotherapy-intolerant patients following radical pancreatic cancer resection.

Secondary objectives focus on evaluating preliminary efficacy through three parameters: 1) XP-004-induced antigen-specific CD4+/CD8+ T cell activation levels, 2) recurrence-free survival (RFS), and 3) overall survival (OS) in post-operative pancreatic cancer patients receiving this combination therapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-11
• Study Start: 2024-10-16
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Subjects voluntarily signed written informed consent files,Able to comply with the study protocol, in the investigator's judgment
2. Subjects must be >/= 18 years of age at time of informed consent, regardless of gender
3. Patients who have been confirmed by pathology to have pancreatic malignant tumors and have undergone radical surgery for pancreatic malignant tumors for 1-3 months
4. No copy number variations (CNVs) or loss of heterozygosity (Loss-of heterozygosity, LOH) were found in HLA-related genes and chromosomal regions by gene sequencing
5. Having tumor tissue confirmed by immunohistochemistry, capable of performing WES and RNAseq sequencing, and predicted by bioinformatics analysis, it was found that there is at least one antigen in the table that has been effectively presented by self-HLA, such as KRAS or TP53 mutations and corresponding HLA subtypes
6. According to the investigator's assessment, the patient is unable to tolerate chemotherapy, such as the score of the Eastern Cooperative Oncology Group (ECOG) Performance Scale ≥ 2 points

Exclusion Criteria

1. Has had chemotherapy, traditional Chinese medicine with antitumor indications, or other antitumor therapies deemed to conflict with the current treatment by the investigator within 4 weeks prior to the first administration of the study drug
2. History of interstitial lung disease (ILD), pulmonary fibrosis
3. Other serious and/or uncontrollable diseases, which may affect the subject's participation in this study, include but not limited to a) a history of severe drug allergy, or is known to be allergic to any tumor vaccine and PD-1 inhibitor formulation components or has had severe allergic reactions to other monoclonal antibodies in the past, b) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases
4. Researchers believe that there are other reasons that are not suitable for participating in clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized neoantigen vaccine + PD-1	Personalized tumor preventive vaccines	Personalised mRNA vaccine combined with PD-1 inhibitor treatment every 3 weeks, 3 weeks as a treatment cycle, a total of 13 cycles.
Neoantigen based vaccines + PD-1 inhibitor	Fixed neoantigen tumor vaccine	A sequential treatment of single/fixed target mRNA vaccines (4 cycles) followed by Personalised mRNA vaccines (9 cycles), in combination with PD-1 inhibitor treatment every 3 weeks, 3 weeks as a treatment cycle, a total of 13 cycles.
Neoantigen based vaccines + PD-1 inhibitor	personalized neoantigen tumor vaccine	A sequential treatment of single/fixed target mRNA vaccines (4 cycles) followed by Personalised mRNA vaccines (9 cycles), in combination with PD-1 inhibitor treatment every 3 weeks, 3 weeks as a treatment cycle, a total of 13 cycles.
Neoantigen based vaccines + PD-1 inhibitor	PD-1 inhibitor	A sequential treatment of single/fixed target mRNA vaccines (4 cycles) followed by Personalised mRNA vaccines (9 cycles), in combination with PD-1 inhibitor treatment every 3 weeks, 3 weeks as a treatment cycle, a total of 13 cycles.

Primary Outcome Measures

Name	Time	Method
Drug related toxicity	18 months	Percentage Participants with Adverse Events (AEs) by severity According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Secondary Outcome Measures

Name	Time	Method
Reaction of antigen-specific T cells in peripheral blood	Up to 18 months	personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses
Recurrence-free survival (RFS)	Up to 18 months	Recurrence-free survival of Personalized mRNA Tumor Vaccine
overall survival (OS)	Up to 18 months	Overall Survival of Personalized mRNA Tumor Vaccine

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China