Actively Recruiting
A Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors
Led by JIANG LONGWEI · Updated on 2024-05-28
6
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
Sponsors
J
JIANG LONGWEI
Lead Sponsor
N
Nanjing University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if tumor neoantigen-specific T cells can treat patients with advanced solid tumors. The main questions it aims to answer are: Evaluate the safety of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer. To evaluate the effectiveness of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer and to study its immunological properties in patients.
CONDITIONS
Official Title
A Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Patients with solid malignant tumors confirmed by histology or cytology such as ovarian cancer, non-small cell lung cancer, or colorectal cancer
- Cancer patients who have failed previous standard treatments or refused further chemotherapy with expected survival over 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patients of childbearing age must use appropriate contraception before and during the study
- Able to understand the study and provide informed consent
- Able to follow the study protocol and attend follow-up visits
You will not qualify if you...
- Received any form of immunotherapy within the past 3 months
- Need to use immunosuppressants
- Received chemotherapy, radiotherapy, or secondary or higher surgery within the past month
- History of other tumors, except treated cervical cancer in situ, treated squamous cell carcinoma, bladder epithelial tumor (Ta and TIS), or other malignancies treated at least 5 years prior
- White blood cell count less than 3 x 10^9/L or platelet count less than 80 x 10^9/L
- Elevated liver enzymes (AST and ALT) or bilirubin above specified limits
- Creatinine clearance below 60 ml/min
- Abnormal blood coagulation
- Active bacterial or fungal infection of grade 2 or higher
- Positive for hepatitis B or C virus with high viral loads, HIV antibody positive, positive for cytomegalovirus DNA, or positive for syphilis
- Severe liver, kidney, metabolic, coronary artery, asthma, or cerebrovascular diseases deemed ineligible by the researcher
- Pregnant or breastfeeding women; women of childbearing age must have a negative pregnancy test within 7 days before enrollment
- Substance abuse or conditions affecting consent or study participation
- Allergy to study drugs
- Participation in other clinical trials within one month before enrollment
- Inability to undergo mononuclear cell separation or lack of peripheral venous access
- Any condition that may affect patient safety or compliance
- Any other reasons deemed unsuitable by the researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nanjing Jinling Hospital
Nanjing, Jiangsu, China, 210002
Actively Recruiting
Research Team
J
Jiang Longwei, Master
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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