NK521 in the Treatment of Advanced Solid Tumors

June 15, 2026 updated by: Base Therapeutics (Shanghai) Co., Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • 1st affiliated hospital of Anhui Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with pathologically confirmed relapsed/refractory advanced solid tumors, including hepatocellular carcinoma and ovarian cancer. Patients enrolled in the intraperitoneal perfusion group (Group B) must have malignant ascites with tumor cells identified in the ascitic fluid.
  • Patients with advanced solid tumors who have received ≥ 1 line of standard therapy.
  • At least one measurable lesion on CT or MRI per RECIST v1.1.
  • ECOG performance status 0-2.
  • Life expectancy ≥3 months.
  • Women of childbearing potential must be non-lactating with a negative serum pregnancy test within 1 week before enrollment; all subjects must agree to use contraception from signing informed consent until 6 months after the last NK521 infusion.
  • Able to comply with the study protocol and follow-up procedures.
  • Voluntarily signed and provided written informed consent.

Exclusion Criteria:

  • Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis.
  • History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or organ transplantation.
  • History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormality requiring clinical intervention (e.g., ventricular arrhythmia, third-degree 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/cerebrovascular events within 6 months before enrollment; NYHA Class ≥II heart failure or left ventricular ejection fraction (LVEF) <50%; uncontrolled hypertension.
  • Received radical radiotherapy within 4 weeks before enrollment; received local palliative radiotherapy within 2 weeks before enrollment.
  • Received cellular antineoplastic therapy within 1 year before dosing; received other antineoplastic therapy outside this protocol within 4 weeks before dosing, including but not limited to chemotherapy, molecular targeted therapy, hormonal therapy, immunotherapy, biotherapy, or Chinese herbal patent medicine with antineoplastic indications.
  • Received blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor therapy within 2 weeks before enrollment.
  • Received systemic therapy with corticosteroids (prednisone >10 mg/day or equivalent) or other immunomodulatory agents (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment. Inhaled or topical corticosteroids are allowed in subjects without active autoimmune disease.

  • Positive virology test for hepatitis B or hepatitis C at screening, meeting any of the following:

    a. HBsAg positive with positive HBV-DNA titer or above upper limit of normal (ULN); b. HCV antibody positive.

  • Meeting any of the following laboratory criteria:a. Hematology: Absolute neutrophil count <1.5×10⁹/L; platelet count <75×10⁹/L; hemoglobin <90 g/L.b. Hepatic function: ALT >3×ULN (≥5×ULN for liver metastasis); AST >3×ULN (≥5×ULN for liver metastasis); TBIL >1.5×ULN, or TBIL >2.5×ULN (3.0 mg/dL) for subjects with Gilbert syndrome.c. Renal function: Serum creatinine >1.5×ULN or creatinine clearance <50 mL/min.
  • Any other severe or uncontrolled medical disease, active infection, abnormal physical examination, abnormal laboratory test, altered mental status, or psychiatric disease that, in the investigator's opinion, increases subject risk or affects study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravenous NK521
NK521 Cell Injection Route: Intravenous infusion Dose level: 1×10⁹, 3×10⁹, 6×10⁹ cells
Biological: NK521 Cell Injection
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.
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
Biological: NK521 Cell Injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The incidence and severity of treatment-emergent adverse events, the occurrence of dose-limiting toxicities, and clinically significant laboratory abnormalities, to evaluate the safety and tolerability of the study treatment.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From the first administration, assessed every 6 weeks until disease progression or death, whichever comes first, up to 24 months.
The proportion of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator using RECIST v1.1 criteria.
From the first administration, assessed every 6 weeks until disease progression or death, whichever comes first, up to 24 months.
Progression-Free Survival (PFS)
Time Frame: From the first administration, assessed every 6 weeks until progression or death, up to 24 months.
Time from first administration to documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
From the first administration, assessed every 6 weeks until progression or death, up to 24 months.
Overall Survival (OS)
Time Frame: From the first administration, followed up every 3-6 months until death or study closure, up to 24 months.
Time from first administration to death from any cause.
From the first administration, followed up every 3-6 months until death or study closure, up to 24 months.
Malignant Ascites Control Rate
Time Frame: From the first intraperitoneal administration, assessed every 3 weeks until the end of treatment, up to 24 months.
The proportion of subjects with reduction in ascites volume (≥50%) and decreased need for paracentesis, assessed using clinical and imaging criteria.
From the first intraperitoneal administration, assessed every 3 weeks until the end of treatment, up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Base Therapeutics (Shanghai) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK521-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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