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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.