Actively Recruiting
Exploratory Clinical Study of Claudin18.2-Targeted CAR-DC and CAR-T Therapy in Advanced Colorectal Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-04-27
18
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Claudin18.2-targeted CAR-DC combined with CAR-T cell therapy in patients with advanced colorectal cancer.
CONDITIONS
Official Title
Exploratory Clinical Study of Claudin18.2-Targeted CAR-DC and CAR-T Therapy in Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with colonic or rectal adenocarcinoma confirmed by tissue biopsy
- At least one measurable tumor lesion meeting RECIST v1.1 criteria
- Positive Claudin18.2 expression confirmed by immunohistochemistry
- Disease has progressed after prior treatments including fluoropyrimidines, irinotecan, and oxaliplatin
- ECOG performance status of 0 or 1
- Expected survival of at least 6 months
- Toxicities from previous treatments resolved to baseline or Grade 1 except alopecia; peripheral neurotoxicity Grade 2 or less allowed
- Minimum washout of 4 weeks for chemotherapy/immunotherapy and 2 weeks for targeted therapy before enrollment
- Adequate organ function including hematologic, hepatic, renal, and coagulation parameters within specified limits
- Use of effective contraception if of childbearing potential
- Able to understand and sign informed consent
- Willing to comply with all study procedures and visits
You will not qualify if you...
- Tumor emergencies requiring immediate treatment such as malignant pericardial effusion, cardiac tamponade, superior vena cava syndrome, or spinal cord compression
- Significant cardiovascular disease or events within past 6 months including myocardial infarction, angina, heart failure, severe arrhythmias, or related procedures
- Prolonged QT/QTcF interval with clinical significance
- Bleeding disorders like hemophilia
- Active infections including HIV, syphilis, or active hepatitis B or C with specific viral load criteria
- History of involuntary psychiatric hospitalization or unsuitable psychiatric conditions
- Autoimmune diseases or chronic use of immunosuppressive or corticosteroid medications
- Poor medication adherence or inability to follow study protocol
- Any other condition judged by investigators to exclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
Y
Ying Yuan
CONTACT
S
Shanshan Weng
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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