Actively Recruiting
CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-10-02
108
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
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
CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, no gender restrictions
- Confirmed advanced, metastatic, or recurrent malignant tumors including colorectal, esophageal, gastric, pancreatic, lung cancer, or cholangiocarcinoma
- Failure of at least second-line standard treatments such as surgery, chemotherapy, or radiotherapy
- Tumor samples positive for CEA with clear membrane staining and positivity rate ≥ 10% within 3 months, or serum CEA > 10 µg/L if older than 3 months
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 to 2
- Expected survival of at least 12 weeks
- No severe psychiatric disorders
- Adequate organ function including blood counts, heart function, kidney and liver function, and oxygen saturation above 92% without supplemental oxygen
- Eligible and able to provide blood for cell collection
- Agreement to use reliable contraception from consent signing until 1 year after CAR-T infusion
- Signed informed consent form agreeing to participate in the trial
You will not qualify if you...
- Symptomatic or uncontrolled central nervous system or meningeal metastasis
- Participation in another clinical trial within 1 month before screening
- Receipt of live attenuated vaccines within 4 weeks before screening
- Anti-tumor treatments such as chemotherapy or targeted therapy within 14 days or 5 half-lives before screening
- Active or uncontrolled infections requiring systemic treatment
- Bowel obstruction, active gastrointestinal bleeding, or severe gastrointestinal conditions within the past 3 months
- Unresolved toxicity from prior treatments above grade 1 except alopecia or peripheral neuropathy
- Serious cardiac conditions including NYHA Class III or IV heart failure, recent myocardial infarction or bypass surgery, significant arrhythmias, or severe cardiomyopathy
- Active autoimmune diseases needing long-term immunosuppressive therapy
- History of other cancers within 3 years except treated stable cervical or basal cell carcinoma
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with abnormal viral loads
- Pregnant or breastfeeding women
- Any other condition deemed 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 901 Hospital of Joint Logistics Support Force of People Liberation Army
Hefei, Anhui, China, 230031
Actively Recruiting
Research Team
D
Donglai Lv, MD
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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