Actively Recruiting
An Exploratory Study on the Treatment of Advanced Solid Tumors by Fast CAR T Cells
Led by Shanghai Cell Therapy Group Co.,Ltd · Updated on 2024-02-08
12
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of fast autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 nanobodies in patients with solid tumors.
CONDITIONS
Official Title
An Exploratory Study on the Treatment of Advanced Solid Tumors by Fast CAR T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with advanced solid tumors showing at least 50% mesothelin expression and PD-L1 positive expression in tumor samples taken within the last 2 years
- Late stage malignant solid tumor patients who have failed or cannot tolerate standard treatments and have no effective standard treatment options
- Age between 18 and 70 years at the time of informed consent
- Life expectancy greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function as defined by specified blood counts, liver function, coagulation, lung and cardiac function
- Measurable disease according to RECIST 1.1 criteria
- Understands the trial and voluntarily signs informed consent
- Agrees to use approved contraceptive methods during the study and for at least 12 months after last CAR-T infusion until no CAR-T cells are detected after two PCR tests
You will not qualify if you...
- Received other anti-tumor treatments (radiation, chemotherapy, immunotherapy, etc.) except allowed lymphocyte depletion within 1 month prior to CAR-T infusion
- Prior gene or T cell therapy including CAR-T cell therapy
- Pregnant or breastfeeding women
- Positive for HIV, syphilis, hepatitis B or C infections as defined
- Active uncontrolled infections, coagulation disorders, or major illnesses
- Autoimmune diseases, organ transplants, immune-related diseases under treatment, or long-term immunosuppressive drug use that cannot be stopped as specified
- Allergy to BZT2312 components
- History of severe cardiac or pulmonary disease including uncontrolled hypertension, recent heart failure, myocardial infarction, or clinically significant heart disease
- Clinically relevant central nervous system metastases or neurological disorders affecting CNS
- High risk for bleeding or perforation
- Major surgery or significant trauma within 4 weeks before apheresis or expected during study
- History of hematologic malignancy or concurrent other malignant solid tumors except certain in situ cancers with no evidence of disease as specified
- Other conditions deemed inappropriate by the investigator for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Mengchao Cancer Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Yong Xia
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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