RecruitingNot ApplicableNCT05749627

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

A Clinical Study of Personalized Tumor Neoantigen Peptide Vaccine/neoantigen-based Dendritic Cells in the Treatment of Advanced Malignant Solid Tumors

Sponsor

The First Affiliated Hospital of Nanchang University

Enrollment

20 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced malignant solid tumors

Summary

In this study, the investigators provide a personalized tumor neoantigen peptide vaccine/neoantigen-based DC treatment to patients with advanced malignant solid tumors. The investigators 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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria15

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 Criteria13

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