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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mesothelin-specific chimeric antigen receptor T cell injection
Sponsored by
Weijia Fang, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • First affiliated hospital, School of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-arm open clinical study

Arm Description

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

Outcomes

Primary Outcome Measures

objective remission rate
objective remission rate

Secondary Outcome Measures

Full Information

First Posted
May 9, 2022
Last Updated
July 14, 2023
Sponsor
Weijia Fang, MD
Collaborators
Nanjing Blue Shield Biotech Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05372692
Brief Title
Study of LD013 in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer
Official Title
Early-stage Clinical Study of Mesothelin-specific Chimericantigen Receptor T Cells (LD013) in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Weijia Fang, MD
Collaborators
Nanjing Blue Shield Biotech Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm open clinical study
Arm Type
Experimental
Arm Description
After blood collection from qualified subjects, lymphocytes will be pretreated，the subjects will then be treated with CAR T cells.
Intervention Type
Drug
Intervention Name(s)
mesothelin-specific chimeric antigen receptor T cell injection
Other Intervention Name(s)
LD013
Intervention Description
Autologous T cell injection
Primary Outcome Measure Information:
Title
objective remission rate
Description
objective remission rate
Time Frame
4-6weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility 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 & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
First affiliated hospital, School of Medicine, Zhejiang University
City
Hangzhou
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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