Actively Recruiting
A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-11-26
48
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
C
Chongqing Precision Biotech Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
CONDITIONS
Official Title
A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Confirmed advanced, metastatic, or recurrent solid tumors including non-small cell lung cancer or breast cancer
- Disease progressed or intolerant after at least second-line standard therapy
- CEA positivity confirmed by immunohistochemistry within 3 months or serum CEA above 10 ng/mL
- At least one measurable lesion per RECIST 1.1 criteria
- For pleural effusion patients, imaging and biopsy confirming malignant pleural effusion
- ECOG performance status between 0 and 2
- Life expectancy of at least 12 weeks
- No serious psychiatric disorders
- Adequate organ function including blood counts, heart, kidney, liver, and oxygen saturation
- Eligible for blood collection without contraindications
- Agreement to use effective contraception for one year after infusion
- Signed informed consent indicating understanding of study purpose and procedures
You will not qualify if you...
- Symptoms or uncontrolled central nervous system metastases
- Participation in another clinical trial within 4 weeks
- Receipt of live vaccine within 4 weeks
- Chemotherapy, targeted therapy, or experimental drugs within 14 days or 5 half-lives
- Active or uncontrolled infection requiring systemic treatment
- Tumor causing significant risk by compressing airway or major vessels
- History of severe cardiac diseases including advanced heart failure, recent myocardial infarction, severe arrhythmias, or cardiomyopathy
- Active autoimmune disease or need for long-term immunosuppressive therapy
- Untreated or recent malignancies within 3 years except certain skin or cervical cancers
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with abnormal viral loads
- Pregnancy or breastfeeding
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310017
Actively Recruiting
Research Team
F
Fuming Qiu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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