Actively Recruiting
An Exploratory Study by Fast CAR T Cells
Led by Shanghai Cell Therapy Group Co.,Ltd · Updated on 2024-03-25
20
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main goal of this trial is to evaluate the safety and tolerability of CAR T cell therapy for advanced solid tumors with positive mesothelin and MUC1.Patients were screened, peripheral blood mononuclear cells (PBMC) were isolated from eligible patients, and cells were prepared. Pretreatment was performed within 5 days before infusion, and CAR T cells were infused on day 0 (the dose was determined according to the requirements of climbing/expansion). The safety intensive observation period was 28 days after infusion, and the clinical efficacy after infusion was evaluated on days 28-34. The follow-up observation and evaluation were carried out according to the follow-up visit point, and the follow-up period was 1 year. From the second year, the telephone follow-up period was entered.
CONDITIONS
Official Title
An Exploratory Study by Fast CAR T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with advanced solid tumors showing at least 50% positive mesothelin and MUC1 expression in tumor samples
- Positive PD-L1 expression in tumor sample taken within last 2 years
- Late-stage solid tumor patients who failed or cannot tolerate standard treatments and have no effective standard plan
- Aged 18 to 70 years at informed consent
- Life expectancy greater than 3 months
- ECOG performance status of 0 or 1
- Satisfactory organ and bone marrow function, including:
- Absolute neutrophil count ≥ 1.5 × 10^9/L, lymphocyte count ≥ 0.5 × 10^9/L, platelets ≥ 90 × 10^9/L, hemoglobin ≥ 90g/L without recent transfusion or erythropoietin dependency
- Total bilirubin ≤ 2 times upper limit normal; ALT/AST ≤ 2.5 times upper limit normal (≤ 5 times if liver metastasis)
- INR or PT ≤ 1.5 times upper limit normal
- Lung function with grade 1 or less dyspnea and oxygen saturation ≥ 91%
- Cardiac ejection fraction ≥ 50% by echocardiogram or MUGA within 1 month
- Measurable disease per RECIST 1.1 criteria
- Understands the trial and signs informed consent
- Agree to use approved contraceptive methods during study and for 12 months after last infusion until CAR-T cells are undetectable by PCR
You will not qualify if you...
- Received other anti-tumor treatments (radiation, chemotherapy, small molecules, biological/immunotherapy, study drugs) except allowed lymphocyte depletion within 1 month before CAR-T infusion
- Prior gene or T cell therapy including CAR-T
- Pregnant or breastfeeding women
- Positive for HIV, syphilis; active hepatitis B or C infection
- Uncontrolled active infection, coagulation disorders, or major illness
- Autoimmune diseases, organ transplantation, or use of immunosuppressive drugs that cannot be stopped as required
- Severe cardiac or pulmonary disease or recent serious cardiac events within 6 months
- Clinically relevant CNS metastases or major CNS diseases
- High risk for bleeding or perforation
- Major surgery or trauma within 4 weeks before apheresis or expected during study
- History of hematologic malignancy or concurrent other primary solid tumors except certain in situ cancers with no disease evidence for years
- Other reasons deemed inappropriate by investigator
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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