Study of LD013 in Subjects With Refractory or Relapsed Me... | NCT05372692

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

NCT05372692

Sponsor

Weijia Fang, MD

Status

Completed

Last Update Posted

Jul 17, 2023Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Ovarian Cancer

Interventions

mesothelin-specific chimeric antigen receptor T cell injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2022Actual

Primary Completion Date

Feb 1, 2023Actual

Completion Date

Feb 1, 2023Actual

First Submitted Date

May 9, 2022

First Submission Date that Met QC Criteria

May 12, 2022

First Posted Date

May 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2023

Last Update Posted Date

Jul 17, 2023Actual

Name	Class
Nanjing Blue Shield Biotech Co.,Ltd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single-arm open clinical study	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mesothelin-specific chimeric antigen receptor T cell injection	Drug	Autologous T cell injection	Single-arm open clinical study

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/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

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40676647	Derived	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.

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases