Actively Recruiting
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-11-08
36
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
T
The First Affiliated Hospital of Nanchang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
CONDITIONS
Official Title
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic 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 such as colorectal, esophageal, gastric, or pancreatic cancer by histology or pathology
- Have experienced failure or intolerance to at least second-line standard treatments including surgery, chemotherapy, or radiotherapy
- Tumor confirmed CEA positive by immunohistochemical staining within 3 months (positive rate ≥ 10%) and serum CEA level above 10 ug/L
- Have at least one assessable lesion based on RECIST 1.1 criteria
- ECOG performance status score of 0 to 2
- No serious mental disorder
- Adequate vital organ function including: white blood cells >3.0×10^9/L, neutrophils >0.8×10^9/L, lymphocytes >0.5×10^9/L, platelets >75×10^9/L, hemoglobin >80g/L; cardiac ejection fraction ≥50% and normal ECG; serum creatinine ≤2.0×ULN; ALT and AST ≤3.0×ULN (≤5.0×ULN if liver tumor infiltration); total bilirubin ≤3.0×ULN; oxygen saturation ≥95% without oxygen
- Eligible for apheresis or venous blood collection with no contraindications
- Agree to use effective contraception for one year after CAR-T infusion (except rhythm contraception)
- Willing and able to provide informed consent
You will not qualify if you...
- Presence of central nervous system or meningeal metastasis deemed unsuitable by investigator
- Participation in other clinical studies within 1 month prior to screening
- Vaccination with live attenuated vaccine within 4 weeks before screening
- Recent anti-tumor treatments such as chemotherapy, targeted therapy, or experimental drugs within 14 days or less than 5 half-lives
- Active or uncontrolled infections needing systemic treatment
- Intestinal obstruction, active gastrointestinal bleeding, or history of bleeding within 3 months
- Unresolved toxicity from prior anti-tumor therapy greater than grade 1 except alopecia or peripheral neuropathy
- Severe heart conditions including NYHA class III/IV heart failure, recent myocardial infarction or coronary artery bypass within 6 months, significant ventricular arrhythmia, history of unexplained syncope, or severe non-ischemic cardiomyopathy
- Active autoimmune diseases or need for long-term immunosuppressive therapy
- Other untreated malignant tumors within past 3 years except cervical carcinoma in situ or basal cell carcinoma
- Positive for hepatitis B, hepatitis C, HIV, or syphilis with active infection
- Pregnant or breastfeeding women
- Any other condition judged by investigators to be unsuitable for participation
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 Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
F
Fei Li, 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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