Actively Recruiting
A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-09-21
30
Participants Needed
2
Research Sites
229 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
Z
Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA positive late malignant solid tumors, and explore the applicable dose regimen for phase II clinical trials.
CONDITIONS
Official Title
A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older, male or female
- Diagnosed with advanced malignant solid tumors confirmed by histology or pathology, including colorectal, esophageal, gastric, pancreatic, non-small cell lung, breast, or bile duct cancer
- Disease progression or intolerance after standard systemic therapies, with specific treatment line requirements depending on cancer type
- Positive for carcinoembryonic antigen (CEA) in tumor tissue within 3 months before screening or confirmed by re-staining and elevated serum CEA
- At least one measurable target lesion per RECIST 1.1 criteria
- ECOG performance status 0 to 1 for most cancers, 0 to 2 for pancreatic cancer
- Expected survival greater than 12 weeks
- No serious mental disorders
- Adequate vital organ function including blood counts, cardiac, renal, liver function, and oxygen saturation
- Eligible for simple or intravenous blood collection without contraindications for cell collection
- Agree to effective contraception methods for 1 year after cell infusion
- Provide informed consent and understand the study purpose and procedures
You will not qualify if you...
- Previous treatment with CAR-T therapy or other gene-modified cell therapies
- Brain metastases with clinical symptoms or lesions in critical brain areas
- Use of investigational drugs or live vaccines within 4 weeks prior to screening
- Radioactive iodine-125 implantation within 8 weeks prior to screening
- Use of systemic steroids, anti-PD-1/PD-L1 antibodies, chemotherapy, targeted therapy, or investigational agents within specified timeframes before apheresis
- Active or uncontrolled infection requiring treatment within 1 week prior to screening
- Severe gastrointestinal conditions such as intestinal obstruction or recent massive bleeding
- History of severe respiratory disease
- Large uncontrollable serous effusions
- Serious heart conditions including advanced heart failure, recent myocardial infarction, significant arrhythmias, or severe cardiomyopathy
- Active or uncontrolled autoimmune diseases requiring immunosuppressive treatment
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus
- Recent venous embolism requiring anticoagulant therapy
- Other untreated malignancies within the past 3 years except certain skin and cervical cancers
- Pregnant or nursing women and those planning pregnancy within 1 year after treatment
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
2
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Ying Yuan, M.D
CONTACT
W
Weijia Fang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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