SCT-001 CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer (NCT06846424) | Clinical Trial Compass
Not Yet RecruitingPhase 1
SCT-001 CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
China24 participantsStarted 2025-06-01
Plain-language summary
This study is an open-label, dose-escalation, investigator-initiated phase I interventional clinical study. To evaluate the safety, tolerability and preliminary efficacy of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer, and to explore the pharmacokinetic characteristics, biomarker changes and immunogenicity of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer.
In this study, two trial cohorts were set up, cohort 1 was the intraperitoneal route of administration, and the subjects enrolled in cohort 1 needed to meet the conditions for intraperitoneal administration ((1) the subject had a large amount of ascites, (2) the subject was suitable for peritoneal catheterization, (3) the subject had no severe abdominal adhesions, and (4) the subject agreed to undergo intraperitoneal surgical catheterization for intraperitoneal administration); Cohort 2 is the intravenous route.
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:
* Subjects must meet all of the following criteria for admission to this study:
Age≥ 18 years old;
* ECOG performance status score: 0\~2 points or KPS score≥70 points;
* Relapsed or refractory epithelial ovarian, fallopian tube and peritoneal cancer confirmed by histology or cytology and have failed, are intolerant or have no standard treatment after standard therapy;
* Tumor tissue specimens or tumor samples can be obtained by tumor biopsy and other methods;
* Immunohistochemistry (IHC) staining confirmed that the tumor cells had positive TAG-72 expression (positive definition: \>). IHC staining intensity of 1% tumor cells ≥2+);
* Estimated survival time of more than 3 months;
* At least one evaluable tumor lesion according to RECIST 1.1;
* Prior to treatment, major organ function met the following criteria (no blood transfusion, long-acting EPO, long-acting G-CSF therapy within 14 days prior to study drug administration, in the case of short-acting EPO, short-acting G-CSF, this criterion can be shortened to 7 days):
* complete blood count: Absolute neutrophil count (ANC) ≥1.5×109/L,, Absolute lymphocyte count (ALC) ≥ 0.5×109/L; hemoglobin (HGB) ≥ 80 g/L; Platelets (PLT) ≥ 75×109/L;
* Renal: serum creatinine ≤1.5× upper limit of normal range (ULN);
* Liver: total bilirubin ≤ 1.5× ULN (including patients with liver metastases or liver cancer), AST and ALT ≤ 2.5× ULN (liver metastases ≤5×ULN);
* Coagulation: International normalized ratio (INR) or prothr…
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.