Safety and Efficacy of NK510 to Treat NSCLC
ConditionNSCLC
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBase Therapeutics (Shanghai) Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years, male or female.
For pleural perfusion group (Group D1/D2): Advanced NSCLC with malignant pleural effusion ≥500ml (confirmed by B-ultrasound or CT); patients with driver gene-positive and resistant to targeted therapy are acceptable.
At least one CT or MRI measurable lesion according to RECIST v1.1.
ECOG performance status 0-2.
Disqualifiers
Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis.
Active, known or suspected autoimmune diseases (excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic treatment [e.g., vitiligo, psoriasis, alopecia] or diseases not expected to recur without external triggers).
History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, grade III atrioventricular block); QTc interval >480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade ≥3 cardiovascular and cerebrovascular events within 6 months before enrollment; NYHA cardiac function class ≥II or left ventricular ejection fraction (LVEF) <50%; clinically uncontrolled hypertension.
Blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor treatment within 2 weeks before enrollment.
Trial design
Treatments tested in this trial
- NK510
- Tislelizumab，atezolizumab or sugemalimab
- NK510
- systemic therapy as selected by the investigator
Treatment groups
12 Participants
are divided into 5 treatment groupsSponsors and collaborators
Base Therapeutics (Shanghai) Co., Ltd.
Lead sponsor
Jinling Hospital, China
Collaborator
Source ClinicalTrials.gov