Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors (NCT03393962) | Clinical Trial Compass
By InvitationPhase 1/2
Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors
China20 participantsStarted 2025-12-01
Plain-language summary
This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of ovarian cancer-specific, engineered immune effectors (OC-EIEs) in women.
Who can participate
Age range
10 Years – 80 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
. Written, informed consent obtained prior to any study-specific procedures.
. Age older than 10 years.
. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
. Expected survival ≥ 12 weeks.
. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage II-IV.
. Not pregnant, and on appropriate birth control of childbearing potential.
. Initial hematopoietic reconstitution with
. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
Exclusion criteria
. Patients with ovarian tumors with low malignant potential (i.e. borderline tumors);
. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
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.
What they're measuring
1
Safety of OC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
. Current or recent treatment (within the 14-day period prior to Day 0) with any immune suppressive drug
. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).