Clinical trials

Eligible subjects with advanced hepatocellular carcinoma and ovarian cancer will be divided into two treatment groups based on the volume of ascites. Group A consists of patients with mild ascites, who will receive NK521 via intravenous infusion. Group B includes patients with moderate to severe ascites, who will be treated with investigator-selected systemic regimens combined with intraperitoneal perfusion of NK521. Systemic and local medications will be administered in accordance with the treatment regimens of respective groups, and the safety of the study drug will be monitored. Preliminary anti-tumor efficacy will be assessed using the RECIST 1.1 criteria at Week 6 after the first infusion of NK521. Catheter placement and ascites drainage will be performed 3 days prior to the first intraperitoneal perfusion of NK521. After the initial intraperitoneal perfusion treatment, the therapeutic effect on ascites will be evaluated per the WHO criteria for ascites assessment.

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.

Study Population: Adult subjects aged 18-75 years with relapsed/refractory advanced solid tumors (including liver, gastric, colorectal, ovarian cancer, etc.) and malignant ascites confirmed by cytology, who have failed at least 2 lines of standard systemic therapy. Study Design: This is a dose-escalation, single-center, open-label, prospective Phase 1 study. A total of 18 subjects will be enrolled and assigned to 2 administration groups (9 subjects each): Group A (Intravenous infusion): For subjects with small-volume malignant ascites. Group B (Intraperitoneal perfusion): For subjects with large-volume symptomatic malignant ascites. Each group will follow a conventional "3+3" dose-escalation design with 3 dose levels (1×10⁹, 3×10⁹, 6×10⁹ NK cells per dose), administered once weekly, 3 weeks per cycle, for 2 consecutive cycles. Primary Objectives: To evaluate the safety and tolerability, and to determine the dose-limiting toxicity (DLT) of NK521 administered intravenously and intraperitoneally. Secondary Objectives: To assess the preliminary anti-tumor efficacy including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), puncture-free survival (PuFS), and changes in tumor markers, as well as health-related quality of life (HRQoL).

This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer and colorectal cancer.NK510 will be administered by intravenous infusion for systemic therapy and intraperitoneal perfusion therapy. The safety and efficacy of this treatment will be evaluated.

This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK510 for the treatment of patients with refractory systemic lupus erythematosus (SLE) in China.

This study will evaluate the safety and efficacy of NK520 in the treatment of relapsed/refractory acute myeloid leukemia. NK520 will be administered by intravenous injection. The safety and efficacy of this treatment will be evaluated.