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Keep this study
Lead
Weijia Fang, MD
With
Nanjing Blue Shield Biotech Co.,Ltd
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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；
You may not be if
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.
Clareo Health | Study of LD013 in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer
