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

NCT ID: NCT05372692

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2023-02-01

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-arm open clinical study

After blood collection from qualified subjects, lymphocytes will be pretreated，the subjects will then be treated with CAR T cells.

Group Type: EXPERIMENTAL

mesothelin-specific chimeric antigen receptor T cell injection

Intervention Type: DRUG

Autologous T cell injection

Interventions

mesothelin-specific chimeric antigen receptor T cell injection

Autologous T cell injection

Intervention Type: DRUG

Other Intervention Names

LD013

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Blue Shield Biotech Co.,Ltd

UNKNOWN

Sponsor Role: collaborator

Weijia Fang, MD

OTHER

Sponsor Role: lead

Responsible Party

Weijia Fang, MD

chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

First affiliated hospital, School of Medicine, Zhejiang University

Hangzhou, , China

Countries

China

References

Chen J, Zhao L, Li W, Wang S, Li J, Lv Z, Zhao Y, Liang J, Hu Z, Pan F, He L, Gu L, Guo Z. Glutamine-driven metabolic reprogramming promotes CAR-T cell function through mTOR-SREBP2 mediated HMGCS1 upregulation in ovarian cancer. J Transl Med. 2025 Jul 17;23(1):803. doi: 10.1186/s12967-025-06853-0.

Reference Type: DERIVED

PMID: 40676647 (View on PubMed)

Other Identifiers

ZhaoPeng

Identifier Type: -

Identifier Source: org_study_id