Actively Recruiting
Anti-Mesothelin CAR-T Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors
Led by Zhejiang University · Updated on 2025-06-08
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
U
UTC Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of Anti-Mesothelin CAR-T cell injection in patients with Mesothelin-positive advanced malignant solid tumors.
CONDITIONS
Official Title
Anti-Mesothelin CAR-T Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Diagnosed with solid tumors that are malignant, refractory to or relapsed after standard therapy, including mesothelioma, pancreatic cancer, biliary tract cancer, lung cancer, ovarian cancer, gastric cancer, bowel cancer, thymic carcinoma, esophageal cancer, breast cancer, or endometrial cancer
- At least one measurable tumor lesion according to RECIST v1.1
- Tumor tissue confirmed positive for mesothelin by immunohistochemistry or immunocytochemistry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate blood, liver, coagulation, kidney, heart, and lung function as defined in the protocol
- Negative pregnancy test for women of childbearing potential
- Willingness to use effective contraception from screening through one year after infusion
- Ability to understand and comply with study protocol and procedures, and willing to sign informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive for hepatitis B surface antigen, active hepatitis B or C infection, HIV, or syphilis
- Unresolved toxicities from prior therapies above grade 1 except hair loss and peripheral sensory nerve disorders
- Received any allogeneic tissue or organ transplant requiring immunosuppression
- Previous treatment with anti-mesothelin CAR-T cell therapy
- Major surgery or severe trauma within 4 weeks before consent or planned major surgery within 12 weeks after cell therapy
- Known central nervous system metastases except stable or asymptomatic brain metastases
- Significant active infections or severe organ dysfunctions that impair treatment tolerance, including uncontrolled infections, heart failure, severe valve disease, abnormal ECG, arrhythmias, recent coronary syndrome, uncontrolled hypertension, recent stroke, severe autoimmune or immunodeficiency diseases
- Severe allergic reactions to study drugs or components
- Received attenuated vaccine or participated in other clinical trials within 4 weeks before consent
- History of other malignancies within 5 years except certain treated skin or carcinoma in situ cancers
- Diagnosed neuropsychiatric diseases such as epilepsy, schizophrenia, dementia, or substance addictions
- Any other condition judged by investigators as 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 Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
Research Team
W
Wenyu Wang, MD PhD
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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