Clinical Study of Personalized Tumor Vaccines mRNA-0217/S001 and Pabolizumab in Patients With Advanced Pancreatic Cancer

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The main objective of this study was to observe and evaluate the safety and tolerability of mRNA-0217/S001 vaccine encoding personalized tumor neoantigens alone/in combination with Pembrolizumab injection for the treatment of Advanced Pancreatic Cancer. The secondary objective was to observe the preliminary efficacy of mRNA-0217/S001 personalized tumor vaccine in the treatment of advanced solid tumors with neoantigen-specific CD4+ and CD8+ T lymphocyte responses, objective tumor response rate (ORR) and disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) caused by mRNA-0217/S001 personalized tumor vaccine.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Subjects voluntarily signed written informed consent files,Able to comply with the study protocol, in the investigator's judgment

• Subjects must be \>/= 18 years of age at time of informed consent, regardless of gender

• Subjects with locally advanced, recurrent or metastatic solid tumors confirmed by histology or cytology within the past 6 months, who have failed standard treatment or are currently not suitable for standard treatment

• 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

• Advanced or metastatic lesions confirmed by immunohistochemistry, and cryopreserved tissues/cells, enough for WES and RNAseq sequencing, and predicted by bioinformatics analysis, at least one antigen effectively presented by self-HLA was found , such as KRAS or TP53 mutations and correspondingly presented HLA types

• Life expectancy ≥ 4 months

• Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions

• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale

• Have adequate organand bone marrow function,No use of granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), red blood cell transfusion and platelet transfusion within 14 days before the examination.

⁃ Fertile eligible patients (male and female) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) during the trial and at least 90 days after the last dose. female patients of childbearing age before the first dose A blood pregnancy test within 7 days must be negative.

⁃ Subjects need to undergo virological examination: those without CMV and EBV, HIV, HBV, HCV, and syphilis infection (only in the baseline period)

Locations
Other Locations
China
Ruijin-Hainan Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Qionghai
Contact Information
Primary
Xinjing Wang
newvista89@163.com
18817821319
Time Frame
Start Date: 2023-04-26
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 54
Treatments
Experimental: Personalized neoantigen vaccine or neoantigen tumor vaccine + Pembrolizumab
In dose escalation phase, subject will only receive personalized neoantigen tumor vaccine. In dose expansion phase, subject will receive personalized neoantigen tumor vaccine combination with Pembrolizumab .
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

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