At a glance
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NCT07435701Phase 2RecruitingMonitorUpdated 3mo ago · Completion was 5mo agoA Single-Arm, Open-Label Phase I/II Clinical Trial of Intraperitoneal Perfusion of SK-NK Cell Injection for the Treatment of Advanced Ovarian Cancer Patients With Massive Ascites
In Brief
A Phase 2 clinical trial evaluating SK-NK Cell Injection for Ovarian Neoplasms Malignant and Ascites. Currently recruiting, targeting 29 participants across 1 site.
Signals
Detailed Summary
This is a single-center, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SK-NK Cell Injection administered via intraperitoneal (IP) perfusion in patients with advanced ovarian cancer complicated by massive ascites . The study focuses on patients who have failed standard therapies and are suffering from severe ascites. The treatment involves the direct infusion of allogeneic, highly activated Natural Killer (NK) cells (SK-NK) into the abdominal cavity . The study consists of two phases: Phase I (Dose Escalation): To determine the safety profile and the Recommended Phase 2 Dose (RP2D) using a "3+3" design with three increasing dose levels. Phase II (Dose Expansion): To further evaluate the efficacy of the treatment in controlling ascites and suppressing tumor growth at the determined RP2D. Participants will receive the study treatment once weekly for 4 weeks.
Study Details
Timeline
Interventions
Administered via intraperitoneal perfusion. Phase I involves a "3+3" dose escalation with three cohorts: 3x10\^8, 6x10\^8, and 9x10\^8 cells. Phase II uses the Recommended Phase 2 Dose (RP2D). The treatment schedule consists of one infusion weekly for 4 weeks (Days 1, 8, 15, and 22). The product is characterized by high purity (\>99%) and high expression of activation markers.