A Study of CCT301-59 CAR T Therapy in Adult Subjects With Recurrent or Refractory Solid Tumors

Inclusion Criteria

• •1. Voluntary to participate in the clinical study, subjects and their family members agree to sign the informed consent form and follow all trial procedures.
• •2. Male or female subjects 18-70 years of age.
• •3. Subjects are diagnosed as recurrent or refractory solid tumors (soft tissue sarcoma, gastric cancer, pancreatic cancer and bladder cancer) with identified unresectable advanced or metastatic tumors by radiology and histology or cytology, progression after the first line or above treatment, or intolerance to standard treatment.
• •4. At least one measurable lesion in accordance with RECIST 1.1, the long diameter of non-lymph node lesions ≥10mm (millimeter) according to CT (computerized tomography) scan-sectional image, or the short diameter of lymph node lesions ≥15mm; the longest axis of the measurable lesion ≥10 mm in CT scan (CT scan layer ≤ 5mm); FDG PET (fluorodeoxyglucose -positron emission tomography) of the measurable lesion \> 3 SUV (standardized uptake values).
• •5. Subjects with ROR2 positive tumor tissue: the percentage of ROR2 positive staining cells in tumor cells detected by immunohistochemistry or RNA (Ribonucleic acid) in situ hybridization is ≥ 50%. The samples could be used within one year , otherwise the sample will be re-collected for biopsy.
• •6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 to 1.
• •7. Expected survival will be ≥ 12 weeks.
• •8. The organ and hematopoietic functions must meet the following requirements:
• •* Hemoglobin (HGB)≥90 g/L (gram per litre), no blood transfusion within two weeks;
• •* White blood cell count (WBC) ≥ 2.5×10\^9/L;
• •* Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L;
• •* Platelet count (PLT) ≥ 80×10\^9/L;
• •* Total bilirubin (TBIL) ≤ 3.0ng/dL or ≤ 5 ULN (Upper Limit of Normal);
• •* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; AST and ALT≤ 5×ULN in case the abnormal hepatic function is caused by hepatocellular carcinoma or liver metastasis from other tumors;
• •* Serum creatinine (Cr) ≤ 1.5×ULN; or creatinine clearance (CrCl) ≥ 50 mL/min (milliliter per minute);
• •9. Prothrombin time (PT): INR (International Normalized Ratio) \<1.7 or prolonged, PT prolonged \< 4 seconds from normal level;
• •10. Normal neurologic evaluation;
• •11. Sufficient venous access for venous intravenous blood collection and infusion, no other contraindications for blood cell separation;
• •12. Able to receive treatment and follow-up, including the treatment at the enrolled site;
• •13. Female subjects of childbearing age must take acceptable measures to minimize the possibility of pregnancy during the trial. The serum or urine pregnancy test must be negative prior to pre-treatment for female subjects of childbearing age;