Actively Recruiting
Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T
Led by Shenzhen University General Hospital · Updated on 2022-11-22
20
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved. Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Preclinical studies suggest that Claudin18.2CAR-T can effectively improve the remission rate of patients with advanced solid tumors.
CONDITIONS
Official Title
Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Voluntary participation with signed informed consent
- Diagnosed with non-resectable, locally advanced recurrent or metastatic gastric or pancreatic cancer confirmed by histopathology
- Cancer stage III or IV according to AJCC TNM staging (8th edition, 2017)
- Measurable lesions according to RECIST 1.1 criteria
- Tumor tissues show moderate to high Claudin 18.2 expression confirmed by immunohistochemical staining
- Have received first- and second-line standard treatment regimens
- Not suitable for radical treatment like chemotherapy, radiotherapy, surgery, or checkpoint immunosuppressants, or refuse surgical resection
- No antibody drugs used within 2 weeks before cell therapy
- ECOG performance score between 0 and 2
- No contraindication for peripheral blood collection
- Expected survival time more than 3 months
You will not qualify if you...
- Allergy to any component of the cell products
- Blood test results showing WBC ≤ 1 × 10^9/L, ANC ≤ 0.5 × 10^9/L, ALC ≤ 0.5 × 10^9/L, or platelets ≤ 25 × 10^9/L
- Lab tests with total serum bilirubin ≥ 1.5 mg/dl; ALT or AST over 2.5 times the upper normal limit; or blood creatinine ≥ 2.0 mg/dl
- Cardiac insufficiency NYHA Grade III or IV or left ventricular ejection fraction < 50%
- Abnormal lung function with blood oxygen saturation under 92% in room air
- Serious heart conditions within 12 months, including myocardial infarction, angioplasty, stenting, or unstable angina
- Grade 3 hypertension poorly controlled by medication
- Past brain trauma, consciousness disorders, epilepsy, severe cerebral ischemia or hemorrhage
- Autoimmune diseases, immunodeficiency, or requiring immunosuppressive treatment
- Uncontrolled active infections
- Previous use of any CAR-T or genetically modified T cell therapy
- Received live vaccine within 4 weeks before enrollment
- Positive for HIV, HBV, HCV, or syphilis tests, or HBV carriers
- History of alcohol or drug abuse, or mental illness
- Participation in other clinical trials within 3 months
- Female participants who are pregnant, breastfeeding, planning pregnancy, or fertile without effective contraception
- 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
Li Yu
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
L
Li Yu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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