NCT07435701

Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites

A 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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background and Rationale: Ovarian cancer often presents with malignant ascites in advanced stages, which is associated with poor prognosis and severely reduced quality of life. The peritoneal cavity in these patients is characterized by an immunosuppressive tumor microenvironment. Natural Killer (NK) cells are innate immune effector cells capable of recognizing and killing tumor cells without MHC restriction. "Super Kill-NK" (SK-NK) cells are highly activated allogeneic NK cells derived from healthy donors, characterized by high expression of activation markers (e.g., CD16, NKG2D) and enhanced cytotoxicity. Intraperitoneal delivery allows for direct contact between effector cells and tumor cells within the peritoneal cavity, potentially increasing local therapeutic concentration while minimizing systemic toxicity . Study Design: This is an open-label, single-arm, Phase I/II study. Phase I (Dose Escalation): Utilizing a standard "3+3" design to assess safety and identify the Dose-Limiting Toxicity (DLT). Three dose cohorts are planned: 3×10\^8, 6×10\^8, and 9×10\^8 cells per dose. The DLT observation period is 28 days after the first infusion. Phase II (Dose Expansion): Once the Recommended Phase 2 Dose (RP2D) is determined, additional patients will be enrolled to evaluate efficacy. Intervention: Eligible patients will receive SK-NK Cell Injection via intraperitoneal perfusion. The treatment schedule consists of one infusion every week for a total of 4 doses (Days 1, 8, 15, and 22). Objectives: Primary: To evaluate safety, tolerability, and determine the RP2D. Secondary: To assess the Ascites Response Rate, Objective Response Rate (ORR), Duration of Relief (DoR), and 1-year Overall Survival (OS). Pharmacokinetics (PK) and pharmacodynamics (PD) will also be evaluated by monitoring SK-NK cell persistence and cytokine levels in peripheral blood and ascites . Exploratory: To investigate the mechanism of action of NK cell therapy in the malignant ascites microenvironment.

Conditions

• Ovarian Neoplasms Malignant
• Ascites

Interventions

Type	Name	Description
BIOLOGICAL	SK-NK Cell Injection	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.

Timeline

• Start date: 2026-01-05
• Primary completion: 2026-01-23
• Completion: 2026-12-31
• First posted: 2026-02-27
• Last updated: 2026-03-17

Locations

1 site across 1 country: China