Personalized neoantigen vaccine treatment for advanced solid tumors
A Clinical Study of Personalized Tumor Neoantigen Peptide Vaccine/neoantigen-based Dendritic Cells in the Treatment of Advanced Malignant Solid Tumors
This study is testing a personalized vaccine treatment for people with advanced solid tumors to see if it can help their immune system fight the cancer better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Nanchang University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Nanchang, Jiangxi) |
| Trial ID | NCT05749627 on ClinicalTrials.gov |
What this trial studies
This study provides a personalized tumor neoantigen peptide vaccine and neoantigen-based dendritic cell treatment for patients with advanced malignant solid tumors. It involves collecting blood samples for sequencing and bioinformatics analysis to identify neoantigens specific to each patient. Participants will receive 5-6 subcutaneous injections over a 14-week treatment period, followed by three follow-up visits to monitor tumor burden and immune response. The aim is to evaluate the effectiveness and safety of this personalized immunotherapy approach.
Who should consider this trial
Good fit: Ideal candidates include patients with inoperable advanced malignant solid tumors who have failed standard treatments and have a life expectancy of at least three months.
Not a fit: Patients with operable tumors or those who are currently undergoing other anti-tumor treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced malignant solid tumors.
How similar studies have performed: While personalized neoantigen therapies are a novel approach, similar studies have shown promising results in enhancing immune responses against tumors.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nanchang, Jiangxi
- First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
Study contacts
- Study coordinator: Sujun Li, PhD
- Email: 17600699826@163.com
- Phone: 8617600699826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.