Actively Recruiting
Safety and Efficacy of NK510 to Treat NSCLC
Led by Base Therapeutics (Shanghai) Co., Ltd. · Updated on 2026-03-20
12
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
B
Base Therapeutics (Shanghai) Co., Ltd.
Lead Sponsor
J
Jinling Hospital, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed/refractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural effusion. Eligible patients need confirmed measurable lesions; intravenous cohort requires EGFR/ROS1/ALK negativity and disease progression after PD-(L)1 inhibitor treatment, while intrapleural cohort accepts targeted therapy-resistant patients with ≥500ml pleural effusion, and the treatment's safety, efficacy and immune microenvironment changes will be evaluated.
CONDITIONS
Official Title
Safety and Efficacy of NK510 to Treat NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Confirmed advanced NSCLC that is unresectable, non-radiotherapeutic stage III or IV, locally advanced, recurrent, or metastatic
- Negative for EGFR, ROS1, and ALK mutations for dose expansion groups
- Disease progression after at least 4 courses of PD-(L)1 blockade with or without chemotherapy
- Advanced NSCLC with malignant pleural effusion of 500 ml or more for pleural perfusion groups
- Patients resistant to targeted therapy with driver gene-positive status accepted in pleural perfusion groups
- At least one measurable lesion on CT or MRI according to RECIST v1.1
- ECOG performance status between 0 and 2
- Expected survival of 3 months or longer
- Previous therapy toxicities resolved to grade 1 or baseline except alopecia and fatigue
- Fertile females must be non-lactating and have a negative pregnancy test within 1 week before enrollment
- All participants must agree to use contraception during the study and for 6 months after last NK510 dose
- Ability to follow study procedures and attend follow-up visits
- Voluntary signing of informed consent
You will not qualify if you...
- Symptomatic central nervous system metastasis or carcinomatous meningitis
- Active, known, or suspected autoimmune diseases except certain controlled conditions
- History of severe cardiovascular or cerebrovascular diseases including serious arrhythmias, recent major cardiac events, or uncontrolled hypertension
- Blood transfusion or treatment with erythropoietin, G-CSF, or GM-CSF within 2 weeks before enrollment
- Systemic corticosteroids over 10 mg/day prednisone equivalent or other immunosuppressive drugs within 2 weeks before enrollment
- Known allergy or intolerance to PD-(L)1 inhibitors
- Significant blood abnormalities such as low neutrophils, platelets, or hemoglobin
- Abnormal liver function tests beyond specified limits
- Impaired kidney function with high serum creatinine or low creatinine clearance
- Any other severe or uncontrolled medical conditions, active infections, mental illnesses, or lab abnormalities that increase risk or affect study results according to investigator assessment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jinling hospital, affiliated to Medical school Nanjing University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
J
Jun Yan, PhD
CONTACT
T
Tangfeng Lv
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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