Actively Recruiting
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant Solid Tumors
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-11-13
60
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
F
First Affiliated Hospital of Wannan Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CART cell preparations, and to reliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CART cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
CONDITIONS
Official Title
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant 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 confirmed by histology or pathology, mainly colorectal, esophageal, gastric, and pancreatic cancers
- Have failed at least second-line standard treatments (disease progression or intolerance) such as surgery, chemotherapy, or radiotherapy
- Tumor tissue immunohistochemically confirmed CEA positive with membrane staining positive rate ≥ 10% within 3 months, and serum CEA level above 10 µg/L
- At least one measurable lesion according to RECIST 1.1 criteria (extranodal lesion length/diameter ≥ 10 mm; lymph node short diameter ≥ 15 mm)
- ECOG performance status score of 0 to 2
- No serious mental disorders
- Adequate vital organ function including specified blood counts, cardiac function, renal and liver function, total bilirubin, and oxygen saturation ≥ 95% without oxygen
- Meet standards for apheresis or blood collection with no contraindications
- Agree to use effective contraception methods for 1 year after CAR-T infusion
- Provide informed consent and agree to participate in the clinical trial
You will not qualify if you...
- Central nervous system or meningeal metastases judged unsuitable for inclusion
- Participation in other clinical trials within 1 month before screening
- Live attenuated vaccine received 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 GI bleeding within 3 months
- Large uncontrolled fluid accumulation in serous cavities
- Previous anti-tumor therapy toxicity not improved to baseline or ≤ grade 1 (except alopecia or neuropathy)
- Heart diseases including NYHA stage III/IV heart failure, recent myocardial infarction or bypass surgery, significant arrhythmias, severe cardiomyopathy
- Active autoimmune diseases or requiring long-term immunosuppressive therapy
- Other untreated malignant tumors within past 3 years (except in situ cervical carcinoma or basal cell skin carcinoma)
- Positive for hepatitis B, hepatitis C, HIV, or syphilis with abnormal viral load or test results
- Pregnant or breastfeeding women
- 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: 1 location
1
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Actively Recruiting
Research Team
L
lili Sheng, 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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