NK521 in the Treatment of Advanced Solid Tumors

Sponsor
Base Therapeutics (Shanghai) Co., Ltd.
Study ID
NCT07657416
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • NK521 Cell Injection — BIOLOGICAL
    Gene-edited natural killer (NK) cell product with knockout of TIGIT, NKG2A, and TGF-β, administered via intravenous infusion or intraperitoneal perfusion for the treatment of malignant ascites associated with advanced solid tumors.
  • NK521 Cell Injection — BIOLOGICAL
    Gene-edited natural killer (NK) cell product with knockout of TIGIT, NKG2A, and TGF-β, administered via intravenous infusion or intraperitoneal perfusion for the treatment of malignant ascites associated with advanced solid tumors.

Study Details

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.

Key Dates

First listed
Jun 18, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intravenous NK521
    NK521 Cell Injection Route: Intravenous infusion Dose level: 1×10⁹, 3×10⁹, 6×10⁹ cells
  • Experimental: Intraperitoneal NK521
    NK521 Cell Injection Route: Intraperitoneal perfusion Dose: 1×10⁹, 3×10⁹, 6×10⁹ NK cells per administration Regimen: Once weekly, 3 weeks per cycle, for 2 consecutive cycles, plus investigator-selected systemic therapy

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events and dose-limiting toxicities [Safety and Tolerability] [ Time Frame: Treatment-emergent adverse events are recorded from the first administration until the final follow-up visit, up to 24 months, and dose-limiting toxicities are monitored within the 28-day period after the last administration. ]

Central Contacts

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