Trial Title:
Using Neoantigen Peptide Vaccine/Neoantigen-based DC to Treat Advanced Malignant Solid Tumors
NCT ID:
NCT05749627
Condition:
Advanced Malignant Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Neoantigen Peptide Vaccine
Neoantigen-based Dendritic Cells
Therapeutic immune preparation
Advanced Malignant Solid Tumors
Progression-free Survival
Overall Survival
Overall Response Rate
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Neoantigen peptide vaccine
Description:
Personalized tumor neoantigen peptide vaccine
Arm group label:
Neoantigen peptide vaccine/neoantigen-based DC treatment
Intervention type:
Drug
Intervention name:
Neoantigen-based DC immune preparation
Description:
Personalized tumor neoantigen DC therapeutic immune preparation
Arm group label:
Neoantigen peptide vaccine/neoantigen-based DC treatment
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.
Detailed description:
This study is conducted in accordance with the Declaration of Helsinki and the guidelines
of the Consolidated Standards of Reporting Trials.
20 patients with primary or metastatic melanoma, gastrointestinal tumor, breast cancer,
cervical cancer, pancreatic cancer, lung cancer, or other malignant tumors will be
recruited in this study. With doctor's assessment, a personalized tumor neoantigen
peptide vaccine or neoantigen-based DC treatment plan will be designed for each
participant：
1. Collecting venous blood samples;
2. Blood PBMC exome sequencing;
3. RNA transcriptome sequencing;
4. Classifying HLA alleles;
5. Performing bioinformatics analysis, finding meaningful mutations and about 10
neoantigen sequences for each patient;
6. Synthesizing peptide neoantigens;
7. Preparation of the personalized tumor neoantigen peptide vaccine or generating the
personalized tumor neoantigen DC therapeutic immune preparation.
Participants will receive 5-6 subcutaneous injections of the vaccine or DC preparation
within a treatment period of 14 weeks. After treatment, participants will have 3
follow-up visits during 9-months. Venous blood collection, physical examination, ECOG
Performance Status Scale assessment, CT/MRI scan, X-ray examination, laboratory
examination, and other necessary examinations are required at each follow-up visit.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Contact:
Last name:
Sujun Li, PhD
Phone:
8617600699826
Email:
17600699826@163.com
Contact backup:
Last name:
Aiping Le
Start date:
April 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Nanchang University
Agency class:
Other
Collaborator:
Agency:
Shanghai Dengding BioAI Co.
Agency class:
Other
Source:
The First Affiliated Hospital of Nanchang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05749627
