Study of LD013 in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer

This is a single-arm, open, dose-increasing, and extended early-stage clinical study of mesothin-specific chimeric antigen receptor T cells (LD013) in patients with mesothelin-positive drug-resistant relapsed ovarian cancer. This study included two phases: dose escalation and extension.

Inclusion criteria

Fully understand and voluntarily sign informed consent.

• Aged at least 18 years old，female.
• Expected survival > 12weeks.
• Eastern Cooperative Oncology Group (ECOG) score 0or1.
• Staining of mesothelin must be greater than 50% of the cells in the tumor tissue and with apparent expression in the membrane. Tissue obtained for the biopsy must be ≤2year prior to enrollment for screening, not have been previously irradiated or exposed to chemotherapy. If unavailable, new tissue material from a recently obtained surgical or diagnostic biopsy is mandatory for this trial；

Exclusion criteria

• Prior treatment with any CART therapy targeting any target.
• Subjects with severe mental disorders.
• Subjects with other malignant tumors.
• Patient is positive for Syphilis, Human Immunodeficiency Virus (HIV) , active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA (qualitative) is detected).
• Detectable clinically relevant central nervous system (CNS) metastases and/or pathology such as epilepsy/seizure, brain Ischemia/ hemorrhage, dementia, cerebellar disease, or autoimmune disease affecting central nervous system；
• Patients with ongoing or active infection.
• Subjects not appropriate to participate in this clinical study judged by investigators.