Clinical Trial

SCT-001 CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer

Not Yet Recruiting Phase 1
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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.
Trial Details
NCT Number NCT06846424
Lead Sponsor Shanghai Gynecologic Oncology Group
Conditions Ovarian Cancer, Fallopian Tube Carcinoma, Peritoneal Carcinoma
Enrollment 24 participants
Start Date 2025-06-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2030-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-26