| Eligibility |
Inclusion Criteria:
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
9. Have adequate organ and 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.
10. 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.
11. Subjects need to undergo virological examination: those without CMV and EBV, HIV, HBV,
HCV, and syphilis infection (only in the baseline period)
Exclusion Criteria:
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 therapy 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%.
9. Other serious and/or uncontrollable diseases, which may affect the subject's
participation in this study, include but not limited to a) a history of severe drug
allergy, or is known to be allergic to any tumor vaccine and pembrolizumab formulation
components or has had severe allergic reactions to other monoclonal antibodies in the
past, b) A history of immunodeficiency, including HIV positive or other acquired or
congenital immunodeficiency diseases, c) Evidence of severe or uncontrolled liver or
kidney disease, d) Uncontrolled high blood pressure, diabetes, etc., e) Patients with
active ulcers, gastrointestinal bleeding, f) Serious infection requiring intravenous
antibiotics or hospitalization or uncontrolled active infection within 4 weeks before
the first dose, g) have an active syphilis infection.
10. Participate in other clinical trials within 4 weeks before the first dose (except for
screening failure)
11. Those who are currently receiving systemic steroids (except those who have recently or
currently used inhaled steroids)
12. Pregnant and lactating women
13. Imaging (CT or MRI) shows that the tumor invades large blood vessels and has a
tendency to hemorrhage
14. Have clinically significant thyroid dysfunction, and the investigator judges that they
are not suitable for enrollment
15. Active pneumonia found in chest CT scan during the screening period
16. Uncontrolled pleural effusion, pericardial effusion, or ascites that needs repeated
drainage
17. Subjects who have adverse reactions of the previous anti-tumor therapy have not
recovered to NCI-CTCAE 5.0 grade evaluation = grade 1 (except for hair loss)
18. HBsAg positive and peripheral blood HBV DNA detection value is higher than the upper
limit of normal, and/or HCV Ab positive and HCV RNA detection value is higher than the
upper limit of normal
19. Researchers believe that there are other reasons that are not suitable for
participating in clinical trials
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