A Phase I Clinical Study of CD70-targeting CAR-T Therapy in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CD70-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
• Age ≥18 years old, male or female;
• Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor CD70 expression (tumor CD70 positive (IHC 3+) confirmed by histology or pathology));
• Failure or intolerance after standard treatment (disease progression or intolerance such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.), and there is currently no effective treatment;
• According to the RECIST version 1.1 standard, at least one target lesion with measurable diameter and evaluable, measurable lesions are defined as: extranodal CT scan long diameter ≥ 10mm, lymph node lesions CT scan short diameter ≥ 15mm, scan slice thickness Not larger than 5mm, and has not received local treatment;
• ECOG 0-2 points;
• The expected survival time is more than 12 weeks;
• No serious mental disorder;
• The function of important organs is basically normal:
∙ Hematopoietic function: neutrophils\>1.0×109/L, platelets\>75×109/L, hemoglobin\>80g/L;
‣ Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;
‣ Renal function: serum creatinine≤2.0×ULN;
‣ Liver function: ALT and AST ≤2.0×ULN (for patients with liver tumor infiltration, it can be relaxed to ≤3.0×ULN);
‣ Total bilirubin ≤2.0×ULN (Gilbert syndrome or combined liver tumor infiltration can be relaxed to ≤3.0×ULN);
‣ Oxygen saturation \> 92% in non-oxygen state.
• Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;
⁃ Subjects agree to use reliable and effective contraceptive methods for contraception (excluding safe period contraception) within 1 year after signing the informed consent form to receiving CAR-T cell infusion;
⁃ Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.