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

Weijia Fang, MD

Status: Completed

Conditions: Ovarian Cancer

Treatments: Drug: mesothelin-specific chimeric antigen receptor T cell injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05372692

ZhaoPeng

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Single-arm open clinical study

Experimental group

Description:

After blood collection from qualified subjects, lymphocytes will be pretreated，the subjects will then be treated with CAR T cells.

Treatment:

Drug: mesothelin-specific chimeric antigen receptor T cell injection