Ovarian Cancer
Conditions
Brief summary
Early-stage Clinical Study of mesothelin-specific Chimericantigen Receptor T Cells (LD013) in Subjects With Refractory or Relapsed mesothelin-positive Ovarian Cancer
Detailed description
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.
Interventions
DRUGmesothelin-specific chimeric antigen receptor T cell injection
Autologous T cell injection
Sponsors
Nanjing Blue Shield Biotech Co.,Ltd
Weijia Fang, MD
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective remission rate | 4-6weeks | objective remission rate |
Countries
China
Outcome results
None listed