- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05372692
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 Contact
- Name: ZHAO PENG, doctorate
- Phone Number: 13958124783
- Email: haozhao@126.com
Study Locations
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-
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Hangzhou, China
- First affiliated hospital, School of Medicine, Zhejiang University
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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
16 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.
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Autologous T cell injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective remission rate
Time Frame: 4-6weeks
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objective remission rate
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4-6weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
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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