RecruitingAdvanced Pancreatic Cancer
Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Ruijin Hospital
You may qualify if…
- ✓ 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. 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
- ✓ 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. 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
- ✓ 6. Life expectancy ≥ 4 months
- ✓ 7. 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
- ✓ 8. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
You may not qualify if…
- ✕ 1. Has had chemotherapy, hormone therapy, traditional Chinese medicine, or biological cancer(for mitomycin and nitrosoureas within 6 weeks from the first dose of the drug in this study)， prior to the first dose of study therapytherapy within 4 weeks ,Or within 5 half-lives of immunotherapy, molecular targeted therapy
- ✕ 2. Subjects have undergone major surgical procedures other than the diagnosis or biopsy of the current tumor within 4 weeks before the first dose of mRNA-0217/S001, or are expected to undergo major surgery during the study period
- ✕ 3. Subjects have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past, or those who plan to receive organ transplantation during this study
- ✕ 4. Subjects have previously received other tumor vaccines or cell therapy
- ✕ 5. Brain metastases with clinical symptoms, spinal cord compression, cancerous meningitis, or other evidence that the brain and spinal cord metastases have not been controlled, and the researchers judged that they are not suitable for enrollment
- ✕ 6. Other malignant tumors known to be progressing or requiring active treatment in the past 2 years (except for non-melanoma skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix that have been cured by surgical curative treatment)
- ✕ 7. History of interstitial lung disease (ILD), pulmonary fibrosis
- ✕ 8. Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to a) severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular block corrected QTc interval male \> 450 milliseconds, female \> 470 milliseconds, b) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration, c) New York Heart Association (NYHA) ≥ III heart failure or left ventricular ejection fraction (LVEF) \< 50%.
Source: ClinicalTrials.gov · NCT05916261 · last updated 2023-10-26