SK-NK Injection in Patients With Advanced Solid Tumors Accompanied by Malignant Ascites
- Conditions
- Solid Tumor, Malignant Ascites
- Interventions
- Drug: SK-NK injection
- Registration Number
- NCT06991478
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
Not provided
- 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.
- Active autoimmune disease.except that the following are allowed to enter the screen: type I diabetes mellitus, hypothyroidism that can be controlled by replacement therapy only, and skin conditions (e.g., vitiligo, psoriasis, or alopecia areata) not requiring systemic therapy.
- Patients had severe cardiovascular disease at screening, with an acute cardiovascular event or pulmonary embolism within the last 6 months or vascular stenting within 6 months; or venous thrombotic disease, such as lower extremity venous thrombosis, within the last 1 month.
- Intestinal obstruction or gastrointestinal bleeding within 30 days prior to enrollment.
- Objective reasons for not being able to drain ascites adequately (including segregation of ascites) or in combination with coeliac ascites.
- Confirmed portal vein embolism or portal hypertension on examination.
- Active chronic hepatitis B, active hepatitis C, positive human immunodeficiency virus (HIV) antibodies or active syphilis infection.
- Combined with pleural effusion and causing clinical symptoms such as chest tightness and dyspnea, requiring clinical intervention as assessed by the investigator; or combined with moderate or greater amounts of pericardial effusion and clinical symptoms.
- Pregnant or lactating women.
- Subjects who, in the judgment of the investigator, have a history of other serious systemic disease or are unfit to participate in this trial for any other reason (the presence of psychiatric disorders, alcohol, drug, or substance abuse in the patient that may affect compliance with the trial, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 1:Dose escalation stage SK-NK injection "3+3" design. SK-NK injection, Two dose groups, namely 20×108 cells and 30×108 cells. Phase 2:Expansion stage SK-NK injection The dose of SK-NK injection selected based on the results of the first stage
- Primary Outcome Measures
Name Time Method SK-NK injection safety and tolerance up to 12 months The incidence of DLT,TEAEs and SAE, and the safety indicators before and after administration
ORR up to 12 months Antitumor efficacy of SK-NK injection
- Secondary Outcome Measures
Name Time Method Pharmacokinetic (PK) characteristics of SK-NK injection; up to 12months To evaluate the AUC0-last of SK-NK injection in patients with advanced or metastatic malignant solid tumors accompanied by malignant ascites
DCR up to 12 months Disease control rate of SK-NK injection
PFS up to 12 months Progression-free survival of SK-NK injection
OS up to 12 months The overall survival of the enrolled patients
Pharmacokinetic (PK) characteristics of SK-NK injection up to 12months To evaluate the t1/2 of SK-NK injection in patients with advanced or metastatic malignant solid tumors accompanied by malignant ascites