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New treatment option for Adrenal Cortical Carcinoma
Official title Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine (mRNA-0523-L001)
ClinicalTrials.gov ID: NCT06141369
What this study is testing
What is individualized mRNA neoantigen vaccine (mRNA-0523-L001)?
individualized mRNA neoantigen vaccine (mRNA-0523-L001) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for adrenal cortical carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The people voluntarily sign the written informed consent form and can comply with the visits and related procedures specified in the protocol;
- The people are 18 years old or older, regardless of gender;
- Patients with advanced endocrine tumors confirmed by histology or cytology in the past 6 months (including medullary thyroid carcinoma, thymic...
- No HLA-related genes or chromosomal regions with copy number variations (CNVs) or loss of heterozygosity (LOH) were detected by gene sequencing;
- They have advanced or metastatic lesions confirmed by immunohistochemistry, and have frozen tissue/cells sufficient for WES and RNAseq sequencing...
You likely can't join if
- Received chemotherapy, hormone therapy, traditional Chinese medicine with anti-tumor indications or other anti-tumor treatments within 4 weeks before...
- Received other major surgery other than diagnosis or biopsy within 4 weeks before the first administration, or expected to receive major surgery...
- Patients who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past, or plan to receive organ...
- Patients who have received other tumor vaccines or cell therapies in the past; Medical condition
- Patients with clinically symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence indicating that the...
- In the past 2 years, there have been known other malignant tumors that are progressing or require active treatment (except for non-melanoma skin...
See the full eligibility criteria
Who can join
- The people voluntarily sign the written informed consent form and can comply with the visits and related procedures specified in the protocol;
- The people are 18 years old or older, regardless of gender;
- Patients with advanced endocrine tumors confirmed by histology or cytology in the past 6 months (including medullary thyroid carcinoma, thymic carcinoma and adrenal cortical carcinoma, etc.), who have failed standard...
- No HLA-related genes or chromosomal regions with copy number variations (CNVs) or loss of heterozygosity (LOH) were detected by gene sequencing;
- They have advanced or metastatic lesions confirmed by immunohistochemistry, and have frozen tissue/cells sufficient for WES and RNAseq sequencing, and after bioinformatics analysis, they predict at least one antigen...
- Expected survival ≥ 4 months;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), they have at least one measurable lesion, which should not have received local treatment such as radiotherapy (lesions in the previous...
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1;
- They have not used granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), red blood cell transfusion or platelet transfusion within 14 days before the examination.
- people of childbearing potential (male and female) who meet the must agree to use reliable contraception methods (hormonal or barrier methods or abstinence) during the trial and for at least 90 days after the last...
- Virology test: No CMV, EBV, HIV, HBV, HCV, syphilis infection (only at baseline)
What rules you out
- Received chemotherapy, hormone therapy, traditional Chinese medicine with anti-tumor indications or other anti-tumor treatments within 4 weeks before the first administration (for mitomycin and nitrosourea, the last...
- Received other major surgery other than diagnosis or biopsy within 4 weeks before the first administration, or expected to receive major surgery during the study;
- Patients who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past, or plan to receive organ transplantation during this study;
- Patients who have received other tumor vaccines or cell therapies in the past; Medical condition
- Patients with clinically symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence indicating that the patient's brain or spinal cord metastases are not controlled, and are...
- In the past 2 years, there have been known other malignant tumors that are progressing or require active treatment (except for non-melanoma skin cancer, superficial bladder cancer, and cervical carcinoma in situ that...
- Have a history of interstitial lung disease (ILD) or pulmonary interstitial fibrosis;
- Have a history of severe cardiovascular and cerebrovascular diseases, including but not limited to: a) Have severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical...
- Other serious and/or uncontrollable diseases that may affect the subject's participation in this study, as determined by the investigator, including but not limited to: a) Have a history of severe drug allergy, or known...
- Participated in other clinical trials within 4 weeks before the first administration (except for screening failure);
- Currently receiving systemic use of corticosteroids (except for recent or current use of inhaled corticosteroids);
- Pregnant or lactating women; Laboratory and imaging examinations
- Imaging (CT or MRI) shows that the tumor invades the large blood vessels and has a tendency to bleed;
- Have clinically significant thyroid function abnormalities, and the investigator deems them unsuitable for enrollment;
- Active pneumonia was found in the screening chest CT scan;
- Uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
- The adverse reactions of previous anti-tumor treatment have not recovered to NCI-CTCAE 5.0 grade evaluation ≤ 1 (except for hair loss);
- Hepatitis B surface antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) test value higher than the upper limit of normal; hepatitis C virus antibody (HCV Ab) positive and HCV...
- The investigator considers that there are other reasons that are not suitable for participating in the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.