Actively Recruiting
Exploratory Study of MSLN-CAR T Cells Secreting PD1/CTLA-4 Nanoantibody for the Treatment of Advanced Solid Tumors
Led by Shanghai Cell Therapy Group Co.,Ltd · Updated on 2024-02-08
16
Participants Needed
1
Research Sites
208 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 autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 and CTLA-4 nanobodies (αPD1/CTLA-4-MSLN-CAR T cells) in patients with solid tumors.
CONDITIONS
Official Title
Exploratory Study of MSLN-CAR T Cells Secreting PD1/CTLA-4 Nanoantibody for the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a histological or cytological diagnosis of advanced solid tumors such as non-small-cell lung cancer or mesothelioma
- Patients must have failed established standard anti-cancer therapies
- Age between 18 and 70 years on the day of signing informed consent
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Mesothelin staining greater than 50% of tumor cells with apparent membrane expression and positive PD-L1 expression in tissue obtained within 3 years prior to enrollment
- Adequate bone marrow function: neutrophil count ≥ 1.5x10^9/L, lymphocyte count ≥ 0.5x10^9/L, platelets ≥ 90x10^9/L, hemoglobin ≥ 90g/L without recent transfusion or dependency on EPO
- Liver function: total bilirubin ≤ 2.0 times upper limit of normal, ALT/AST ≤ 2.5 times upper limit (≤ 2.5 if hepatic metastasis present)
- Kidney function: creatinine ≤ 1.5 times upper limit or eGFR ≥ 60 ml/min/1.73m²
- Coagulation: INR or PT ≤ 1.5 times upper limit of normal
- Lung function: dyspnea CTCAE grade ≤ 1 and oxygen saturation ≥ 91%
- Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or MUGA within one month before enrollment
- Measurable disease per RECIST 1.1 criteria
- Ability to understand the trial and provide informed consent
- Agreement to use approved contraceptive methods during the study and for 12 months after last cell infusion until no CAR-T cells detected after two PCR tests
You will not qualify if you...
- Prior therapy with targeted therapy or cell therapy against mesothelin
- Prior gene therapy or any T cell therapy
- Active uncontrolled bacterial, viral, or fungal infections
- Positive for Syphilis, HIV, active Hepatitis B or Hepatitis C
- Medical conditions requiring chronic systemic steroids or other immunosuppressive medications
- History of severe cardiac or pulmonary disease including uncontrolled hypertension, recent congestive heart failure (NYHA class ≥3), cardiac interventions, myocardial infarction, unstable angina, or other significant heart disease within past 6 months
- Clinically relevant central nervous system metastases or neurological conditions like epilepsy, brain ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune CNS disease
- History or current evidence of neurotic, psychiatric, immune, metabolic, or infectious diseases that might interfere with study participation
- Known hematologic malignancy or concurrent other primary solid tumor except certain in situ cancers with long disease-free intervals
- Recent chemotherapy, radiotherapy, biological cancer therapy, immunotherapy, or investigational drugs within 2 weeks prior to study
- Pregnant or breastfeeding women
- Any other condition or therapy that the investigator feels would interfere with study participation or is not in the patient's best interest
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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