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

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

Sponsors

Lead Sponsor: Weijia Fang, MD

Collaborator: Nanjing Blue Shield Biotech Co.,Ltd

Source Zhejiang University
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.

Overall Status Recruiting
Start Date 2022-04-12
Completion Date 2026-02-01
Primary Completion Date 2026-02-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
objective remission rate 4-6weeks
Enrollment 9
Condition
Intervention

Intervention Type: Drug

Intervention Name: mesothelin-specific chimeric antigen receptor T cell injection

Description: Autologous T cell injection

Arm Group Label: Single-arm open clinical study

Other Name: 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.

Gender:

Female

Gender Based:

Yes

Gender Description:

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

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: ZHAO PENG, doctorate

Phone: 13958124783

Email: [email protected]

Location
Facility: Status: Contact: First affiliated hospital, School of Medicine, Zhejiang University Weijia Fang, Doctor
Location Countries

China

Verification Date

2022-05-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Zhejiang University

Investigator Full Name: Weijia Fang, MD

Investigator Title: chief physician

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Single-arm open clinical study

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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