Study of LD013 in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer (NCT05372692) | Clinical Trial Compass
CompletedNot Applicable
Study of LD013 in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer
China3 participantsStarted 2022-04-12
Plain-language summary
Early-stage Clinical Study of mesothelin-specific Chimericantigen Receptor T Cells (LD013) in Subjects With Refractory or Relapsed mesothelin-positive Ovarian Cancer
Who can participate
Age range18 Years
SexFEMALE
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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 systemï¼›
* Patients with ongoing or active infection.
* Subjects not appropriate to participate in this clinical study judged by investigators.