Safety and Efficacy of NK510 to Treat NSCLC

Sponsor
Base Therapeutics (Shanghai) Co., Ltd.
Study ID
NCT06097962
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NK510 — DRUG
    Intravenous infusion
  • Tislelizumab，atezolizumab or sugemalimab — DRUG
    Administer according to the instructions
  • NK510 — DRUG
    intrapleural infusion
  • systemic therapy as selected by the investigator — DRUG
    Administer according to the instructions

Study Details

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.

Key Dates

Start date
Jul 1, 2023
Status verified
Sep 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (low-dose group)
    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.
  • Experimental: Group B (medium-dose group)
    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..
  • Experimental: Group C (high-dose group)
    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..
  • Experimental: Group D1 (low-dose group)
    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.
  • Experimental: Group D2 (high-dose group)
    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.

Primary Outcome Measure

Dose-limiting toxicity and incidence of adverse events [ Time Frame: 6 weeks ]

Central Contacts

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