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

Shanghai Jiao Tong University

Status and phase: Enrolling; Early Phase 1

Conditions: Pancreatic Cancer Resectable; Chemotherapy-intolerant

Treatments: Biological: personalized neoantigen tumor vaccine; Drug: PD-1 inhibitor; Biological: Fixed neoantigen tumor vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06496373

2023PCV004

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Neoantigen based vaccines + PD-1 inhibitor

Experimental group

Description:

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.

Treatment:

Biological: Fixed neoantigen tumor vaccine

Drug: PD-1 inhibitor

Biological: personalized neoantigen tumor vaccine