Advanced Lung Cancer
Conditions
Interventions
Group 1:NCK-1512 cells, secreting IL-15 (12.5 ng/kg/day) and IL-12 (30 ng/kg/day), are administered via infusion
Group 2:NCK-1512 cells, secreting IL-15 (37.5 ng/kg/day) and IL-12 (90 ng/kg/day), are administered via infusion
Group 3:NCK-1512 cells, secreting IL-15 (112.5 ng/kg/day) and IL-12 (270 ng/kg/day), are administered via infusion
Sponsors
The General Hospital of the Eastern Theater Command of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and =1.5 × 10^9/L, and platelet count >=60 × 10^9/L; (if not met at screening, the participant may be enrolled if repeat testing meets the criteria within the required 2-week screening window); 6. Hepatic and renal function: total bilirubin =50 mL/min; 7. Echocardiography shows left ventricular ejection fraction (LVEF) >=50%; 8. No active infection; 9. Estimated life expectancy >3 months; 10. In the investigator’s judgment, no difficulty in peripheral blood collection and no contraindications to peripheral blood collection; 11. The participant or his/her legally authorized representative voluntarily agrees to participate in this study and signs the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of allergy to any component of the cell product (exception: participants who received prior NK cell therapy where more than 5 half-lives have elapsed since the last dose); 2. Uncontrolled intracranial metastases (except for asymptomatic brain metastases with no expected need for corticosteroid treatment within 4 weeks after the first cell infusion); 3. Unresolved toxicity from prior antitumor therapy (toxicity not recovered to = Grade 1 per NCI-CTCAE v5.0), except alopecia; 4. Active upper gastrointestinal disease within 4 weeks, such as upper gastrointestinal bleeding, gastric ulcer, etc.; 5. Receipt of antitumor chemotherapy, immunotherapy, or other antitumor treatment within 2 weeks prior to infusion; 6. Systemic corticosteroid therapy within 2 weeks prior to infusion, and in the investigator’s judgment requiring long-term systemic corticosteroids during treatment (inhaled or topical use is allowed); 7. History of severe cardiac disease, such as acute myocardial infarction within 12 months, coronary angioplasty or stent implantation within 12 months, unstable angina, or chronic heart failure >= NYHA Class III, etc.; 8. History of severe cerebrovascular events (except those without significant neurological dysfunction, such as lacunar cerebral infarction, etc.); 9. Clinically significant QT interval prolongation (screening resting corrected QT interval [QTc]: female >470 ms or male >450 ms) or a history of severe arrhythmia; 10. Poorly controlled hypertension (either not receiving standard treatment, or hypertension not controlled despite standard treatment: systolic blood pressure >=160 mmHg or diastolic blood pressure =100 mmHg) or poorly controlled diabetes mellitus; 11. Uncontrolled active infection (simple urinary tract infection or bacterial pharyngitis is allowed); 12. HBsAg positive with HBV DNA >1000 copies (participants with HBV DNA =1000 copies may be enrolled but must receive routine anti-HBV antiviral therapy after enrollment); positive for HCV, HIV, or syphilis antibodies, or with DNA testing above the upper limit of normal; 13. Autoimmune disease requiring treatment, or requiring immunosuppressive therapy; 14. History of alcohol abuse, drug abuse, or psychiatric illness; 15. Participation in other immunotherapy clinical trials within 4 weeks prior to screening; 16. Pregnant or breastfeeding women, and subjects of childbearing potential who cannot use effective contraception (regardless of sex); 17. Any other condition that, in the investigator’s opinion, may increase the subject’s risk or interfere with the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity rates;Incidence rate of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Progression-free survival period;Overall survival; | — |
Countries
China
Contacts
Public ContactTangfeng Lv
The General Hospital of the Eastern Theater Command of the People's Liberation Army of
Outcome results
None listed