Actively Recruiting
Using Neoantigen Peptide Vaccine/neoantigen-based DC to Treat Advanced Malignant Solid Tumors
Led by The First Affiliated Hospital of Nanchang University · Updated on 2025-02-27
20
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Nanchang University
Lead Sponsor
S
Shanghai Dengding BioAI Co.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Using Neoantigen Peptide Vaccine/neoantigen-based DC to Treat Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with inoperable advanced malignant solid tumors such as melanoma, gastrointestinal tumor, breast cancer, pancreatic cancer, cervical cancer, or lung cancer
- Have failed standard treatment or voluntarily stopped other treatments at least 2 weeks ago
- Experienced disease progression before treatment
- Expected survival of 3 months or longer
- ECOG performance status of 0, 1, or 2
- Negative pregnancy test for females of childbearing age
- Able to use effective contraception and have no plans to become pregnant within 6 months
- Not positive for HIV, HBV, HCV, or syphilis
- Liver enzymes ALT/AST and ALP no more than 2.5 times the upper normal limit
- Serum creatinine no higher than 1.6 mg/dL
- Total bilirubin no higher than 1.5 mg/dL
- Blood counts within specified limits including lymphocytes > 20%, neutrophil count ≥ 1x10^9/L, white blood cell count ≥ 3x10^9/L, platelet count ≥ 100x10^9/L, hemoglobin > 8.0 g/dL, CD4+ cell count > 200/μL
- Normal coagulation test and ECG
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients with brain metastases
- Received immunosuppressant therapy within 1 month or other immunotherapy within 3 months
- Participated in another clinical study within the past 30 days
- History of severe allergies or severe allergy reactions
- Have had a splenectomy
- Have primary or secondary immunodeficiency or autoimmune diseases such as lupus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, psoriasis, or uncontrolled asthma
- Taken oral, intramuscular, or intravenous corticosteroids within 1 month (inhaled or topical steroids allowed for respiratory issues)
- Have uncontrolled epilepsy, CNS disorders, or neurological diseases causing cognitive loss
- History of chronic alcohol or drug abuse within 6 months
- Unstable systemic diseases such as active infections, liver cirrhosis, chronic renal failure, severe pulmonary disease, unstable hypertension, unstable angina, recent heart failure or myocardial infarction
- History of other malignant tumors within the past 5 years (except clinically cured or certain skin cancers)
- Considered unsuitable for study participation by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
Research Team
S
Sujun Li, PhD
CONTACT
A
Aiping Le
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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