NK521 in the Treatment of Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBase Therapeutics (Shanghai) Co., Ltd.
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
NK521 Cell Injection
Biological/VaccineGene-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/VaccineGene-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.
Treatment groups
18 Participants
are divided into 2 treatment groupsGroup A: Intravenous NK521Experimental treatment 1 intervention
Group B: Intraperitoneal NK521Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events and dose-limiting toxicities [Safety and Tolerability]
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.
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.Secondary outcomes
1
Objective Response Rate (ORR)
The proportion of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator using RECIST v1.1 criteria.
Time frame
From the first administration, assessed every 6 weeks until disease progression or death, whichever comes first, up to 24 months.2
Progression-Free Survival (PFS)
Time from first administration to documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Time frame
From the first administration, assessed every 6 weeks until progression or death, up to 24 months.3
Overall Survival (OS)
Time from first administration to death from any cause.
Time frame
From the first administration, followed up every 3-6 months until death or study closure, up to 24 months.4
Malignant Ascites Control Rate
The proportion of subjects with reduction in ascites volume (≥50%) and decreased need for paracentesis, assessed using clinical and imaging criteria.
Time frame
From the first intraperitoneal administration, assessed every 3 weeks until the end of treatment, up to 24 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: