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

July 14, 2023 updated by: Weijia Fang, MD

Early-stage Clinical Study of Mesothelin-specific Chimericantigen Receptor T Cells (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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hangzhou, China
        • First Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: mesothelin-specific chimeric antigen receptor T cell injection
Autologous T cell injection
Other Names:
  • LD013

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective remission rate
Time Frame: 4-6weeks
objective remission rate
4-6weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weijia Fang, MD

Collaborators

Nanjing Blue Shield Biotech Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2022

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhaoPeng

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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