Safety and Efficacy of NK510 to Treat NSCLC

NCT06097962 | Recruiting Early Phase 1

• 1 other identifier: NK510-06
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

NSCLC

Keywords

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity and incidence of adverse events

  To evaluate DLT and the incidence of AEs associated with NK510 treatment

  6 weeks

• Objective Response Rate

  For intravenous groups: Proportion of subjects achieving CR and PR according to RECIST v1.1 after first NK510 administration; For pleural perfusion groups: Proportion of subjects achieving CR and PR according to WHO criteria after first NK510 intrapleural perfusion.

  6 weeks

Secondary Outcomes (6)

• Progression-Free Survival

  From the date of the first dose of NK510 until disease progression, death, or a maximum of 24 months after the first dose, whichever occurs first.

• Puncture-Free Survival

  From the date of the last treatment puncture to the date of the next puncture drainage, or up to a maximum of 24 months after the last treatment puncture, whichever occurs first.

• Duration of Response

  From the date of first documentation of objective response to disease progression, death, or a maximum of 24 months after the date of first response, whichever occurs first.

• Disease Control Rate

  From baseline tumor assessment up to the earliest of disease progression，or a maximum of 24 months after baseline.

• Overall Survival

  From the date of screening enrollment to death, or a maximum of 24 months after screening enrollment, whichever occurs first.

Study Arms (5)

Group A (low-dose group)

EXPERIMENTAL

NK510 will be administered once a week for a total of six weeks.3×10\^9 NK cells/dose. PD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator.

Drug: NK510; Drug: Tislelizumab，atezolizumab or sugemalimab

Group B (medium-dose group)

EXPERIMENTAL

NK510 will be administered once a week for a total of six weeks.9×10\^9 NK cells/dose. PD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator..

Drug: NK510; Drug: Tislelizumab，atezolizumab or sugemalimab

Group C (high-dose group)

EXPERIMENTAL

NK510 will be administered once a week for a total of six weeks.12×10\^9 NK cells/dose. PD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator..

Drug: NK510; Drug: Tislelizumab，atezolizumab or sugemalimab

Group D1 (low-dose group)

EXPERIMENTAL

Thoracic perfusion therapy will be conducted on Day 1 (D1) and Day 5 (D5) of each 3-week treatment cycle, with 3×10⁹ NK510 cells/dose for each time via intrapleural infusion, for 2 consecutive cycles.

Drug: NK510; Drug: systemic therapy as selected by the investigator

Group D2 (high-dose group)

EXPERIMENTAL

Thoracic perfusion therapy will be administered on Day 1 (D1) and Day 5 (D5) of each 3-week treatment cycle, with 6×10⁹ NK510 cells/dose for each time via intrapleural infusionwith, for 2 consecutive cycles.

Drug: NK510; Drug: systemic therapy as selected by the investigator

Interventions

NK510 DRUG

Intravenous infusion

Group A (low-dose group); Group B (medium-dose group); Group C (high-dose group)

Tislelizumab，atezolizumab or sugemalimab DRUG

Administer according to the instructions

Group A (low-dose group); Group B (medium-dose group); Group C (high-dose group)

systemic therapy as selected by the investigator DRUG

Administer according to the instructions

Group D1 (low-dose group); Group D2 (high-dose group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, male or female.
• For dose expansion group (Group A/B/C):
• A. EGFR mutation-negative, ROS1-negative, and ALK-negative; unresectable and non-radiotherapeutic stage III or IV, locally advanced, recurrent or metastatic NSCLC.
• B. Disease progression after ≥4 courses of PD-(L)1 blockade ± chemotherapy.
• 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.
• Expected survival ≥3 months.
• All toxicities from previous anti-tumor therapy (except alopecia and fatigue) resolved to grade 1 (CTCAE v5.0) or baseline; subjects with long-term sequelae from previous therapy (e.g., neuropathy after platinum-based therapy) are acceptable.
• Fertile females must be non-lactating and have a negative serum pregnancy test within 1 week before enrollment; all subjects (male or female) must agree to use contraception from signing informed consent until 6 months after the last NK510 infusion.
• Able to comply with the study protocol and follow-up procedures.
• Voluntarily sign the informed consent form.

You may not qualify if:

• 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.
• Systemic treatment with corticosteroids (prednisone \>10 mg/day or equivalent) or other immunosuppressive/immunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment; inhalation or topical corticosteroids are allowed in subjects without active autoimmune diseases.
• Known allergy or intolerance to PD-(L)1 blockade.
• Meeting any of the following laboratory criteria:
• Hematology: Neutrophils \<1.5×10⁹/L; Platelets \<75×10⁹/L; Hemoglobin \<90 g/L.
• Liver function: ALT \>3×ULN (≥5×ULN in patients with liver metastasis); AST \>3×ULN (≥5×ULN in patients with liver metastasis); TBIL \>1.5×ULN or \>2.5×ULN (3.0 mg/dL) in patients with Gilbert syndrome.
• Renal function: Serum creatinine \>1.5×ULN or creatinine clearance \<50 mL/min.
• Any other severe or uncontrollable medical diseases, active infections, physical examination abnormalities, laboratory test abnormalities, mental status changes or mental illnesses that increase subject risk or affect study results (assessed by investigator).

Sponsors & Collaborators

• Base Therapeutics (Shanghai) Co., Ltd.: lead
• Jinling Hospital, China: collaborator

Study Sites (1)

Jinling hospital, affiliated to Medical school Nanjing University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

sugemalimab

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Tangfeng Lv, PhD

  Jinling hospital, Nanjing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Yan, PhD

CONTACT

+86 186 2166 8515; yanjun@basetherapeutics.com

Tangfeng Lv

CONTACT

+86 139 5201 6932; bairoushui@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation study

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 24, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)