RecruitingPhase 1Phase 2NCT07435701

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

29 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Ascites Ovarian Neoplasms Malignant

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of immune cell therapy — SK-NK cells (engineered natural killer immune cells) injected directly into the abdomen — for women with advanced ovarian cancer who have significant fluid buildup in the abdomen (ascites). **You may be eligible if...** - You are a woman between 18 and 75 years old - You have advanced ovarian cancer confirmed by biopsy - You have already tried at least two lines of standard treatment that are no longer working or that you cannot tolerate - You have significant fluid buildup in the abdomen - You are in reasonably good health (ECOG 0-2) **You may NOT be eligible if...** - You have not yet tried at least two prior standard treatments - You have active infections or significant immune system problems - You are pregnant or breastfeeding - You have major organ failure that would make the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSK-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.

Locations(1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT07435701

Related Trials

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(1)

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