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CompletedNCT05372692Updated Jul 17, 2023

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

An interventional study of mesothelin-specific chimeric antigen receptor T cell injection in Ovarian Cancer, sponsored by Weijia Fang, MD. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-17.

Sponsored by Weijia Fang, MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Ovarian Cancer
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 3 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Weijia Fang, MD is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • 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

Interventions

  • Drugmesothelin-specific chimeric antigen receptor T cell injection

    Autologous T cell injection

    Also known as: LD013

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What researchers measure

Primary outcomes

  1. objective remission rate

    objective remission rate

    Time frame: 4-6weeks

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Study locations

1 site
  • First affiliated hospital, School of Medicine, Zhejiang University
    Hangzhou, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05372692
Lead sponsor
Weijia Fang, MD
Collaborators
Nanjing Blue Shield Biotech Co.,Ltd
Responsible party
Weijia Fang, MD (chief physician, Zhejiang University) — Sponsor-investigator
First posted
May 13, 2022
Start date
Apr 12, 2022
Primary completion
Feb 1, 2023
Completion
Feb 1, 2023
Last update
Jul 17, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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