NCT05372692

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable ovarian-cancer

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

May 9, 2022

Last Update Submit

July 14, 2023

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • objective remission rate

    objective remission rate

    4-6weeks

Study Arms (1)

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

mesothelin-specific chimeric antigen receptor T cell injectionDRUG

Autologous T cell injection

Also known as: LD013
Single-arm open clinical study

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEarly-stage Clinical Study of mesothelin-specific Chimericantigen Receptor T Cells (LD013) in Subjects With Refractory or Relapsed mesothelin-positive Ovarian Cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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；

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First affiliated hospital, School of Medicine, Zhejiang University

Hangzhou, China

Location

Related Publications (1)

  • 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.

    PMID: 40676647DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 13, 2022

Study Start

April 12, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)