Actively Recruiting
Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors
Led by Weijia Fang, MD · Updated on 2026-01-23
18
Participants Needed
1
Research Sites
175 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 FAST targeted chimeric antigen receptor (CAR)-T cells (PTC13) in patients with carcinoembryonic antigen (CEA)-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of FAST CAR-T (PTC13) and phase II Recommended dose.
CONDITIONS
Official Title
Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with advanced, metastatic, or recurrent malignant tumors confirmed by pathology, including colorectal, esophageal, gastric, pancreatic, lung cancer, or cholangiocarcinoma
- Failed at least second-line standard therapy or lack effective treatment options
- Tumor tissue tested positive for carcinoembryonic antigen (CEA) within 3 months, or serum CEA >10 µg/L if older than 3 months
- At least one measurable lesion by RECIST 1.1 criteria
- ECOG performance score of 0 to 2
- No severe psychiatric disorders
- Adequate organ function including blood counts, cardiac, renal, liver function, and oxygen saturation >92%
- Eligible for apheresis or blood collection without contraindications
- Agree to use effective contraception from consent signing until 1 year after CAR-T infusion
- Patient or guardian agrees to participate and signs informed consent
You will not qualify if you...
- Symptomatic or uncontrolled central nervous system or leptomeningeal metastases
- Participation in another clinical trial within 1 month before screening
- Received live attenuated vaccines within 4 weeks before screening
- Received chemotherapy, targeted therapy, or experimental drugs within 14 days or 5 half-lives before screening
- Active or uncontrolled infections needing systemic treatment
- Intestinal obstruction, active gastrointestinal bleeding, recent major GI bleeding within 3 months, severe ulcers, or severe inflammatory bowel disease
- Toxicity from prior anti-tumor therapy not improved to baseline or grade 1, except alopecia or peripheral neuropathy
- Significant cardiac conditions including NYHA class III/IV heart failure, recent myocardial infarction or bypass surgery, serious arrhythmias, or severe cardiomyopathy
- Active autoimmune diseases or requiring long-term immunosuppression
- Another untreated cancer diagnosed within 3 years except in situ cervical cancer or basal cell skin cancer
- Positive for hepatitis B, hepatitis C, HIV, or syphilis with abnormal viral levels
- Pregnant or breastfeeding women
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
W
Weijia Fang, MD
CONTACT
Y
Yang Gao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here