Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Esophageal Cancer and Non-small Cell Lung Cancer

Summary: A single arm, open-label pilot study is designed to determine the safety, tolerability and effectiveness of personalized mRNA tumor vaccine encoding neoantigen in Patients with advanced esophageal cancer and non-small cell lung cancer

Detailed description: Primary objectives:
  Assessing the safety and tolerability of mRNA personalized tumor vaccines encoding neoantigen for unresectable or metastatic advanced esophageal and non-small cell lung cancers with standard treatment failure or no standard treatment.
  Secondary objectives:
  Preliminary observation of the efficacy of mRNA personalized tumor vaccines encoding neoantigen for unsurgically resected or metastatic advanced esophageal and non-small cell lung cancers with standard treatment failure or no standard treatment.
  Time of tumor progression (TTP); Disease Control Rate (DCR); Objective Remission Rate (ORR); Overall Survival (OS).

Eligibility: Inclusion Criteria:
  1. Patients Age 18 to 75 years old (including both ends)
  2. The primary lesion was confirmed by pathology or cytology as esophageal cancer and non-small cell lung cancer;
  3. Receive a biopsy before treatment;
  4. Patients with fertility must agree to use reliable methods of contraception (hormone or barrier or abstinence) during the trial and at least 12 weeks after the last treatment;
  5. The primary lesion was confirmed by pathology or cytology as esophageal cancer and non-small cell lung cancer;
  6. Patients with unresectable or metastatic esophageal cancer (IIIC (T4bNanyM0, TanyN3M0), stage IV) and non-small cell lung cancer (stage IIIB, IV) with standard treatment failure or no standard treatment;
  7. According to the solid tumor evaluation standard RECIST (version 1.1), at least one measurable tumor lesion (spiral CT scan tumor maximum diameter ≥ 10 mm);
  8. ECOG score 0~1;
  9. The number of lymphocytes is ≥800/μL, the number of absolute neutrophils is ≥1,500/μL, hemoglobin ≥10 g/dL; WBC≥2.5×109/L, PLT≥75×109/L, MID≥1.5×109/L, LY≥0.4×109/L; serum Alb≥30 g/L; serum lipase and amylase<1.5 ULN; serum creatinine≤1.5 ULN; ALT≤2.5 ULN, AST≤2.5 ULN, alkaline phosphatase ≤ 2.5 ULN; AST, ALT and alkaline phosphatase <5 ULN in the presence of bone or liver metastasis; serum urea nitrogen ≤ 3 ULN; serum total bilirubin ≤ 1.5 ULN; prothrombin time ( PT) extended ≤ 4s;
  10. Subjects volunteered to participate and signed informed consent in writing.
  Exclusion Criteria:
  1. Allergic constitution or a history of allergies to biopharmaceuticals; 2. Pregnant or lactating women; 4. The tumor mutation load (TMB) is less than 2.0/Mb or the tumor neonatal antigen load (TNB) is less than 0.5/Mb or the predicted number of nascent antigens is less than 3; 5. Patients with untreated brain metastases or symptoms of brain metastases (patients with stable brain metastases can be enrolled); 6. There are a wide range of tumor lung metastases, leading to difficulty breathing; 7. Patients with tumors close to large blood vessels or nerves; 8. History of severe cardiovascular and cerebrovascular diseases, including but not limited to ventricular arrhythmias requiring clinical intervention; acute coronary syndrome, myocardial infarction, congestive heart failure, stroke or other grade III and above within 6 months Cardiovascular events; New York Heart Association (NYHA) cardiac function classification ≥ II or left ventricular ejection fraction (LVEF) < 50%; hypertension still controlled by standard treatment (systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg); 9. There are currently patients with active ulcers and gastrointestinal bleeding; 10. Patients with clinically diagnosed autoimmune diseases; HIV, HCV positive; HBsAg positive; those with acute EBV or CMV infection; 11. Patients with a history of organ transplantation or waiting for an organ transplant; 12. Any uncontrollable active person; 13. Subjects with immunosuppression, including known immunodeficiency; those currently on systemic use of steroids (except those who have recently or recently used inhaled steroids); 14. Skin diseases such as psoriasis may prevent intradermal injection of vaccine into the target area; 15. Anti-tumor treatments such as chemotherapy, biotherapy, radiation therapy, endocrine therapy, and targeted therapy were administered within 28 days prior to the first administration of mRNA tumor vaccine (in which fluorouracil oral drugs such as tigio, capecitabine, and finally One oral dose may be administered at least 14 days between the first dose of mRNA tumor vaccine, or other test drug treatment, or surgery (without diagnostic biopsy); 16. Adverse reactions to previous anti-tumor treatment have not been restored to CTCAE (version 4.03) grade evaluation ≤ 1 (except for hair loss); 17. The investigator assessed that the subject was unable or unwilling to comply with the requirements of the study protocol.
  18. Previous chemotherapy, severe myelosuppression

Relevance to patient case: not relevant