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

Not Applicable

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: mesothelin-specific chimeric antigen receptor T cell injection

• Registration Number: NCT05372692
• Lead Sponsor: Weijia Fang, MD

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.

Study Timeline

• Study Start: 2022-04-12
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-13
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3

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；

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single-arm open clinical study	mesothelin-specific chimeric antigen receptor T cell injection	After blood collection from qualified subjects, lymphocytes will be pretreated，the subjects will then be treated with CAR T cells.

Primary Outcome Measures

Name	Time	Method
objective remission rate	4-6weeks	objective remission rate

Trial Locations

Locations (1)

First affiliated hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, China