Actively Recruiting
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2024-08-09
60
Participants Needed
3
Research Sites
155 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
S
Shanxi Bethune Hospital
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
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Diagnosed with advanced, metastatic, or recurrent malignant tumors such as colorectal, esophageal, gastric, or pancreatic cancer confirmed by histology or pathology
- Have failed at least second-line standard treatment due to disease progression or intolerance
- Tumor confirmed CEA positive by immunohistochemical staining within 3 months with a positive rate of 10% or higher
- Serum CEA level exceeding 10 ug/L
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 to 2
- No serious mental disorders
- Adequate vital organ function, including blood counts, cardiac, renal, liver function, and oxygen saturation as specified
- Eligible for apheresis or venous blood collection without contraindications
- Agree to use reliable contraception during the study and up to one year after CAR-T infusion
- Provide informed consent and agree to participate in the clinical trial
You will not qualify if you...
- Presence of central nervous system or meningeal metastasis deemed unsuitable by investigators
- Participation in another clinical study within 1 month before screening
- Vaccination with live attenuated vaccine within 4 weeks before screening
- Received chemotherapy, targeted therapy, or experimental drugs within 14 days or 5 half-lives before screening
- Active or uncontrolled infection requiring systemic treatment
- Intestinal obstruction, active gastrointestinal bleeding, or history of gastrointestinal bleeding within 3 months
- Unresolved toxicity from previous cancer treatments greater than grade 1 except alopecia or peripheral neuropathy
- Severe heart conditions such as NYHA class III/IV heart failure, recent myocardial infarction or coronary artery bypass, significant arrhythmias, or severe cardiomyopathy
- Active autoimmune diseases or need for long-term immunosuppressive therapy
- Other untreated cancers within past 3 years except certain skin or cervical cancers
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis outside normal ranges
- Pregnant or breastfeeding women
- Any other condition the investigator deems unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Actively Recruiting
2
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Actively Recruiting
3
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Actively Recruiting
Research Team
Q
Qi Mei, M.D
CONTACT
S
Shuang Wei, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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