Using Neoantigen Peptide Vaccine/Neoantigen-based DC to Treat Advanced Malignant Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this study, we provide a personalized tumor neoantigen peptide vaccine/neoantigen-based DC treatment to patients with advanced malignant solid tumors. We observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the neoantigen-based DC treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Nanchang University
• Collaborator: Shenzhen Dengding Biopharma Co. Ltd.

Criteria

Inclusion Criteria:

• With inoperable advanced malignant solid tumors, including melanoma, gastrointestinal tumor, breast cancer, pancreatic cancer, cervical cancer, lung cancer, etc.

• Failed in standard treatment or voluntarily give up other treatment, and been longer than 2 weeks from the end of the last anti-tumor treatment

• Had disease progression prior to treatment

• Expected survival ≥ 3 months

• ECOG performance status of 0, 1, or 2

• With a negative pregnancy test for females of childbearing age

• Able to take effective contraceptive measures and ensure that there is no birth plan within half a year of the study

• Not positive for HIV, HBV, HCV, or TP

• ALT/AST ≤ 2.5 times the upper limit of normal

• ALP ≤ 2.5 times the upper limit of normal

• Serum creatinine ≤1.6 mg/dL

• Total bilirubin ≤ 1.5 mg/dL

• In the absence of granulocyte colony-stimulating factor support, proportion of lymphocytes > 20%, absolute neutrophil count ≥ 1x10^9/L, white blood cell count ≥ 3x10^9/L, platelet count ≥ 100×10^9/L, hemoglobin > 8.0 g/dL, CD4+ cell count > 200/μL

• With normal coagulation test and ECG

• Able to understand and willing to sign a written informed consent form

Exclusion Criteria:

• Pregnant or breastfeeding women

• Patients with brain metastases

• Had immunosuppressant therapy within 1 month or received other immunotherapy within 3 months

• Participated in other clinical study within 30 days

• With severe allergies or histories of severe allergy

• With splenectomy

• With primary or secondary immunodeficiency diseases or autoimmune diseases (including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, psoriasis, uncontrolled asthma, etc.)

• Had oral, intramuscular, or intravenous corticosteroids within 1 month. However, inhaled corticosteroids are allowed to treat respiratory insufficiency (such as chronic obstructive pulmonary disease), as well as topical steroids

• With uncontrollable epilepsy, central nervous system disorder, or neurological disease with loss of cognitive ability

• With a history of chronic alcohol or drug abuse within 6 months

• With unstable systemic diseases (including active infection, liver cirrhosis, chronic renal failure, severe chronic pulmonary disease, unstable hypertension, unstable angina, congestive heart failure, myocardial infarction within 1 year, etc.)

• With a history of other malignant tumors in the past 5 years (excluding those who have been clinically cured, and squamous cell carcinoma or skin basal cell carcinoma)

• Those the researcher believed inappropriate to participate in this study