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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372692
• Other study ID #: ZhaoPeng
• Status: Completed
• Phase: N/A
• Start date: April 12, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: July 2023
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• mesothelin-specific chimeric antigen receptor T cell injection
Autologous T cell injection

Locations

Country	Name	City	State
China	First affiliated hospital, School of Medicine, Zhejiang University	Hangzhou

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective remission rate	objective remission rate	4-6weeks