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

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

Detailed Description
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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.

Official Title
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Early-stage Clinical Study of Mesothelin-specific Chimericantigen Receptor T Cells (LD013) in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: mesothelin-specific chimeric antigen receptor T cell injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm open clinical study<br>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<br>* Autologous T cell injection<br>* Other names: LD013;|

What is the study measuring?
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Primary Outcome Measures

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