Advanced solid tumors
Conditions
Interventions
Dose Level 1:NK cell injection solution (NC001) cells. Using the Bayesian Optimal Interval (BOIN) design, three preset dose groups (5.0×10^8 cells biweekly, 1×10^9 cells biweekly, 3×10^9 cells biweekl
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in this study, signing the informed consent form, good compliance, and able to cooperate with follow-up; 2. Age between 18 and 75 years old (inclusive of the boundaries), both genders are eligible; 3. Locally advanced or metastatic solid tumors diagnosed by histopathology or cytopathology, with failure of adequate standard treatment or no effective standard treatment. Standard treatment failure is defined as: failure according to the standard treatment protocol stipulated in the 2025 CSCO guidelines, such as at least 2 lines of standard systemic anti-tumor treatment (if there is only 1 line of treatment recommended for the tumor type, then it is based on the standard 1-line treatment), and confirmed by the investigator or recorded in the medical history as clear disease progression or intolerable toxicity; 4. At least one measurable extracranial lesion that meets the RECIST v1.1 criteria; 5. ECOG score: 0-1; 6. Expected survival period >= 12 weeks; 7. The functions of important organs meet the following requirements (no use of any blood components or cell growth factors within 7 days before the first administration): (1) Laboratory indicators of hematology, including: A. White blood cell count (WBC) >= 3.0 × 10^9/L; B. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; C. Platelet count (PLT) >= 100 × 10^9/L; D. Hemoglobin (Hb) >= 90 g/L. (2) Renal function, including: A. Serum creatinine (Cr) = 60 mL/min. (3) Cardiac function, including: A. Left ventricular ejection fraction (LVEF) >= 50%; B. Fridericia method corrected male QTc <= 450 msec, female QTc <= 470 msec; (4) Liver function, including: A. Serum total bilirubin (TBIL) <= 1.5 × ULN; B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 × ULN (for patients with liver metastasis, ALT and AST <= 5 × ULN); (5) Coagulation function, including: A. International normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; B. Activated partial thromboplastin time (APTT) <= 1.5 times ULN. 8. Non-surgical sterilized women of childbearing age need to adopt effective contraceptive measures during the study treatment period and within 6 months after the study treatment period, and male patients whose partners are women of childbearing age need to adopt effective contraceptive measures during the study treatment period and within 3 months after the study treatment period; Non-surgical sterilized women of childbearing age must have a negative serum HCG test within 7 days before the first administration and must be non-lactating.
Exclusion criteria
Exclusion criteria: If the subjects meet any of the following criteria, they will not be included in this study: 1. The subjects have had or are currently suffering from other malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ (DCIS), other malignant tumors that have been fully treated and cured for at least 3 years and have no evidence of recurrence or metastasis, as confirmed by sufficient treatment before the first medication administration. 2. The subjects have cancerous meningitis, or have untreated central nervous system metastasis; if they have received systemic, radical brain metastasis treatment (radiation or surgery), such as if the imaging shows stability and has been maintained for at least 1 month, and have stopped systemic hormone therapy (dose > 10mg/day prednisone or other equally effective hormones) for more than 2 weeks, and have no clinical symptoms, they can be included. 3. Within 3 months before the first medication administration, the subjects have experienced intestinal obstruction or gastrointestinal perforation. 4. There is third-space effusion that cannot be controlled by drainage (such as a large amount of ascites, pleural effusion, pericardial effusion). 5. Within 6 months before the first medication administration, the subjects have had poorly controlled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart function insufficiency (2) unstable angina pectoris (3) acute myocardial infarction has occurred within 1 year (4) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention. 6. The subjects have idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia (only if the imaging shows it and no hormone treatment is required), drug-induced pneumonia, or the CT shows active pneumonia during the screening period. 7. Within 6 months before the first medication administration, the subjects have experienced thromboembolic events in the arteries or veins, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; they need to receive long-term anticoagulation treatment with warfarin or heparin, or long-term antiplatelet treatment (aspirin >= 300 mg/day or clopidogrel >= 75 mg/day). For those with lower extremity venous thrombosis who have been evaluated not to need anticoagulation treatment, or those with attached thrombus that has disappeared and does not require drug treatment due to catheterization, they can be considered for inclusion. 8. Within 4 weeks, the subjects have concurrent severe infection (such as: according to clinical diagnosis and treatment guidelines, intravenous infusion of antibiotics, antifungal or antiviral drugs is required), or during the screening period or before the first administration, they have had fever > 38.3°C without a clear cause for more than 38.3°C (if the fever is caused by tumor reasons, it can be included). 9. The subjects have congenital or acquired immune deficiency (such as HIV-infected individuals). 10. The subjects have active hepatitis (for hepatitis B: HBsAg positive and HBV DNA >= 500 IU/ml; for hepatitis C: HCV antibody positive and HCV viral copy number > upper limit of normal value); 11. Within 4 weeks before the first medication administration or plan to receive attenuated live vaccines during the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Dose-Limiting Toxicities (DLT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease Control Rate (DCR);Progression-Free Survival (PFS);Overall Survival (OS);Duration of Response (DOR); | — |
Countries
China
Contacts
Public ContactYongqian Shu
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Outcome results
None listed