Actively Recruiting
A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
Led by Weijia Fang, MD · Updated on 2026-04-28
110
Participants Needed
1
Research Sites
292 weeks
Total Duration
On this page
Sponsors
W
Weijia Fang, MD
Lead Sponsor
C
Chongqing Precision Biotech Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
CONDITIONS
Official Title
A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older, male or female
- Diagnosed with advanced, metastatic, or recurrent malignant tumors confirmed by histology or pathology, mainly colorectal cancer
- Received at least second-line standard treatment and failed due to disease progression or intolerance or lack of effective treatments
- Tumor confirmed CEA positive by immunohistochemical staining within 3 months (positive rate �3e�3d 10%) or serum CEA > 10 ug/L if over 3 months
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 to 2
- No serious mental disorder
- Adequate vital organ function including specified blood counts, cardiac, renal, liver function, and oxygen saturation > 92% without oxygen
- Suitable for apheresis or venous blood collection with no contraindications
- Agree to use reliable contraception excluding rhythm method for 1 year after CAR-T infusion
- Provide informed consent and understand the study procedures
You will not qualify if you...
- Central nervous system or meningeal metastases with symptoms or uncontrolled disease
- Participation in other clinical trials within 1 month before screening
- Received live attenuated vaccine within 4 weeks before screening
- Received chemotherapy, targeted therapy, or experimental drugs within 14 days or 5 half-lives prior to screening
- Active or uncontrolled infection requiring systemic treatment
- Intestinal obstruction, active gastrointestinal bleeding, or history of GI bleeding within 3 months
- Toxicity from prior anti-tumor therapy not improved to baseline or grade 1 except alopecia or peripheral neuropathy
- Significant heart disease including NYHA III-IV heart failure, recent myocardial infarction or bypass surgery, serious arrhythmia, or severe cardiomyopathy
- Active autoimmune diseases or requiring long-term immunosuppressive therapy
- Other untreated or concurrent malignant tumors within past 3 years except certain skin or cervical cancers
- Positive hepatitis B, hepatitis C, HIV, or syphilis tests with abnormal viral load
- Pregnant or breastfeeding women
- Any other condition the investigator deems unsuitable for participation
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, Zhejiang University
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
W
Weijia Fang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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