Status:
COMPLETED
Study of LD013 in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer
Lead Sponsor:
Weijia Fang, MD
Collaborating Sponsors:
Nanjing Blue Shield Biotech Co.,Ltd
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05372692
Start Date
April 12 2022
End Date
February 1 2023
Last Update
July 17 2023
Active Locations (1)
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1
First affiliated hospital, School of Medicine, Zhejiang University
Hangzhou, China