Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • NK521 Cell Injection
  • NK521 Cell Injection

Treatment groups

18 Participants
are divided into 2 treatment groups

Locations

1
1st affiliated hospital of Anhui Medical University HefeiAnhui, China

Sponsors and collaborators

Base Therapeutics (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov