SK-NK Injection in Patients With Advanced Solid Tumors Accompanied by Malignant Ascites (NCT06991478) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
SK-NK Injection in Patients With Advanced Solid Tumors Accompanied by Malignant Ascites
10 participantsStarted 2025-05-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 to 75 years.
. Malignant solid tumors confirmed by histology or pathology, including: advanced gastric cancer, colorectal cancer, esophageal squamous cell carcinoma, gynecological malignancies, etc. that have failed at least two lines of treatment.
. Pathological diagnosis or clinical diagnosis combined with malignant ascites, and ascites drainage is not required within one week before the administration of the study.
. At least one measurable tumor lesion based on RECIST V1.1 criteria.
. ECOG PS ≤1.
. Expected survival ≥12 weeks.
. Adequate organ function.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SK-NK injection safety and tolerance
Timeframe: up to 12 months
2
ORR
Timeframe: up to 12 months
Trial details
NCT IDNCT06991478
SponsorTianjin Medical University Cancer Institute and Hospital
. Non-reproductive female patients, or reproductive female patients whose pregnancy test results are negative and commit to taking adequate and effective contraceptive measures or abstinence from the screening period until 3 months after the last administration, or male patients commit to taking adequate and effective contraceptive measures or abstinence from the screening period until 3 months after the last administration.
Exclusion criteria
. History of severe allergic reactions to protein drugs
. Have received NK cell therapy in the past.
. Untreated, unstable or uncontrolled central nervous system (CNS) metastases.
. Tumor invasion of vital arteries resulting in high risk of bleeding, significant risk of perforation or already formed fistulae.
. Major surgeries within 4 weeks before enrollment or are planned to undergo major surgeries during the trial (excluding exploration surgeries).
. New infections or concurrent infections occurred within 14 days before enrollment and have not yet been controlled to clinical stability.
. Prior to the first study dose, systemic chemotherapy and anti-tumor monoclonal antibody drug therapy has been completed for at least 4 weeks; small molecule targeted drug therapy has been completed for at least 2 weeks or 5 half-lives of the drug (whichever is longer); intraperitoneal chemotherapy has been completed for at least 2 weeks; and treatment with proprietary Chinese medicines approved by the National Medicines and Pharmaceutical Administration (NMPA) as antitumor and having antitumor effects has been completed for at at least 2 weeks.
. Patients with severe respiratory disease at the time of screening that results in respiratory failure or who, in the judgment of the investigator, are not suitable for enrollment.