Actively Recruiting
Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine (mRNA-0523-L001)
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-04-09
21
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Treatment of advanced endocrine tumors, including adrenal corticocarcnioma (ACC), medullary thyroid carcinoma (MTC), thymic neuroendocrine tumor and pancreatic neuroendocrine tumor is challenging. Previous genomic profiling studies showed they presented a number of somatic mutations. The tumors Individualized mRNA neoantigen vaccine provide a promising solution since a significant portion of these tumors showed high quality of tumor specific neoantigen. The primary objective is to observe and evaluate the safety and tolerability of individualized mRNA neoantigen vaccine (mRNA-0523-L001) for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available. The secondary objective is to observe the preliminary efficacy of mRNA-0523-L001 for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available, including: 1. Neoantigen-specific CD4+ and CD8+ T lymphocyte responses induced by mRNA-0523-L001; 2. Objective response rate (ORR) and disease control rate (DCR) of tumors; 3. Progression-free survival (PFS).
CONDITIONS
Official Title
Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine (mRNA-0523-L001)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent and able to comply with study visits and procedures
- Age 18 years or older, any gender
- Advanced endocrine tumors confirmed by histology or cytology within 6 months, including medullary thyroid carcinoma, thymic carcinoma, and adrenal cortical carcinoma
- Failure of standard treatment or no standard treatment available
- No copy number variations or loss of heterozygosity in HLA-related genes by gene sequencing
- Presence of advanced or metastatic lesions confirmed by immunohistochemistry with sufficient frozen tissue/cells for WES and RNA sequencing
- Prediction of at least one antigen effectively presented by own HLA, such as KRAS or TP53 mutations
- Expected survival of at least 4 months
- At least one measurable lesion per RECIST 1.1 criteria, untreated by local therapy (except progressed lesions in prior radiotherapy areas)
- ECOG performance status score of 0 or 1
- No use of G-CSF, GM-CSF, red blood cell transfusion, or platelet transfusion within 14 days before examination
- Agreement to use reliable contraception during the trial and for 90 days after last administration if of childbearing potential
- Negative pregnancy test within 7 days before first administration for women of childbearing age
- Negative baseline virology tests for CMV, EBV, HIV, HBV, HCV, and syphilis
You will not qualify if you...
- Received chemotherapy, hormone therapy, traditional Chinese medicine with anti-tumor effects, or other anti-tumor treatments within 4 weeks before first administration (6 weeks for mitomycin and nitrosourea)
- Received major surgery other than diagnosis or biopsy within 4 weeks before first administration or planned major surgery during study
- History of allogeneic hematopoietic stem cell transplant or organ transplant, or planned organ transplant during study
- Prior tumor vaccines or cell therapies
- Clinically symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or uncontrolled brain/spinal metastases
- Other malignant tumors progressing or requiring active treatment in past 2 years (except certain cured cancers)
- History of interstitial lung disease or pulmonary interstitial fibrosis
- Severe cardiovascular or cerebrovascular diseases including arrhythmias, acute coronary syndrome, heart failure, stroke within 6 months, or LVEF below 50%
- Severe or uncontrollable diseases affecting participation, including severe allergies, immunodeficiency, severe liver or kidney disease, poorly controlled hypertension or diabetes, active ulcers or bleeding, severe infection requiring IV antibiotics or hospitalization, active syphilis
- Participation in other clinical trials within 4 weeks before first administration except screening failure
- Current systemic corticosteroid use except inhaled corticosteroids
- Pregnant or lactating women
- Tumor invading large blood vessels with bleeding tendency
- Clinically significant thyroid dysfunction deemed unsuitable
- Active pneumonia on screening chest CT
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Unresolved adverse reactions from prior anti-tumor treatment above 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-assessed reasons unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
L
Lei Ye
CONTACT
L
Luming Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here