Actively Recruiting
Combination Therapy of Personalized mRNA-0217 Vaccines and Pembrolizumab in Patients With Advanced Solid Tumors
Led by Ruijin Hospital · Updated on 2025-04-01
34
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
S
Shanghai Xinpu BioTechnology Company Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 solid tumors. 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.
CONDITIONS
Official Title
Combination Therapy of Personalized mRNA-0217 Vaccines and Pembrolizumab in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study protocol
- 18 years of age or older
- Locally advanced, recurrent, or metastatic solid tumors confirmed by biopsy or cytology within past 6 months
- No copy number variations or loss of heterozygosity in HLA-related genes by gene sequencing
- Advanced or metastatic lesions sufficient for whole exome sequencing and RNA sequencing showing at least one antigen effectively presented by self-HLA
- Life expectancy of at least 4 months
- Measurable disease per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function without recent use of colony-stimulating factors or transfusions within 14 days
- Fertile patients must agree to use reliable contraception during treatment and for 90 days after last dose; negative pregnancy test within 7 days before first dose for women of childbearing potential
- Negative for CMV, EBV, HIV, HBV, HCV, and syphilis infections at baseline
You will not qualify if you...
- Chemotherapy, hormone therapy, traditional Chinese medicine with antitumor effects, or other antitumor treatments within 4 weeks before first dose
- Major surgery within 4 weeks before first dose or planned during study
- Previous allogeneic stem cell or organ transplantation or planned transplantation during study
- Prior tumor vaccines or cell therapy
- Symptomatic brain metastases, spinal cord compression, cancerous meningitis, or uncontrolled brain/spinal metastases
- Other progressing malignant tumors needing treatment in past 2 years except certain cured cancers
- History of interstitial lung disease or pulmonary fibrosis
- Serious cardiovascular or cerebrovascular diseases including severe arrhythmias, recent acute events, advanced heart failure, or low ejection fraction
- Severe and uncontrolled diseases affecting participation including severe drug allergies, immunodeficiency, uncontrolled liver or kidney disease, active ulcers or infections
- Participation in other clinical trials within 4 weeks before first dose
- Current systemic steroid use (except inhaled steroids)
- Pregnant or breastfeeding women
- Tumor invading large blood vessels with bleeding risk
- Significant thyroid dysfunction
- Active pneumonia on chest CT during screening
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Unresolved adverse reactions from prior anti-tumor therapy higher than grade 1 (except hair loss)
- Positive hepatitis B surface antigen with high viral load or positive hepatitis C antibody with high viral load
- Other investigator-determined reasons unsuitable for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
X
Xinjing Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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