SK-NK Injection in Patients With Advanced Solid Tumors Accompanied by Malignant Ascites

This study is divided into two phases. Patients with recurrent or metastatic solid tumors accompanied by malignant ascites who have failed previous standard treatments are enrolled. The first phase is a single-arm, open-dose exploratory Phase I clinical study. In this phase, two dose groups are preset, namely 20×108 cells and 30×108 cells. Subjects who meet the inclusion criteria will receive intravenous infusion of SK-NK injection. Once a week for 6 consecutive infusions. After completing 6 consecutive infusions of SK-NK injection, the researchers evaluated that the patient benefited and could continue to receive 6 consecutive infusions of SK-NK injection. After completing 12 infusions, whether to continue the treatment subsequently could be determined based on the patient's condition. The second stage will be based on the results of the first stage to further verify the clinical efficacy, safety, tolerability and pharmacokinetic characteristics of RP2D, etc.

NCT Number	NCT06991478
Lead Sponsor	Tianjin Medical University Cancer Institute and Hospital
Conditions	Solid Tumor, Malignant Ascites
Enrollment	10 participants
Start Date	2025-05-30
Primary Completion	2026-05-30 (estimated)
Study Completion	2026-07-30 (estimated)
Updated on ClinicalTrials.gov	2025-05-28