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

• Status: Recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Early-stage Clinical Study of mesothelin-specific Chimericantigen Receptor T Cells (LD013) in Subjects With Refractory or Relapsed mesothelin-positive Ovarian Cancer

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weijia Fang, MD
• Collaborator: Nanjing Blue Shield Biotech Co.,Ltd

Criteria

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.