Hepatocellular Carcinoma (HCC)Early Phase 1NCT07657416
NK521 in the Treatment of Advanced Solid Tumors
A Early Phase 1 study testing NK521 Cell Injection in people with Hepatocellular Carcinoma (HCC) and Ovarian Cancer, run by Base Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Ovarian Cancer, Malignant Ascites
- What is being tested?
- NK521 Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Jan 2027to Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
1st affiliated hospital of Anhui Medical University
Hefei, Anhui
Beicheng Sun, 0551-62923004, ayfykyll@163.com
About this study
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.
- Being tested
- NK521 Cell Injection
- Medical subject headings
- Carcinoma, Hepatocellular, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK521 Cell InjectionBiological
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 InjectionBiological
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 group | Role | What they receive |
|---|---|---|
| Intravenous NK521 | Experimental | NK521 Cell Injection Route: Intravenous infusion Dose level: 1×10⁹, 3×10⁹, 6×10⁹ cells Receives: Biological: NK521 Cell Injection |
| Intraperitoneal NK521 | Experimental | 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 Receives: Biological: NK521 Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (4)
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.
Measured: 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 from first administration to documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: From the first administration, assessed every 6 weeks until progression or death, up to 24 months.
Overall Survival (OS)
Time from first administration to death from any cause.
Measured: From the first administration, followed up every 3-6 months until death or study closure, up to 24 months.
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.
Measured: From the first intraperitoneal administration, assessed every 3 weeks until the end of treatment, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Intravenous NK521 Intervention: NK521 Cell Injection Route: Intravenous infusion Dose level: 1×10⁹, 3×10⁹, 6×10⁹ cells Arm 2: Intraperitoneal NK521Intervention: NK521 Cell Injection Route: Intraperitoneal perfusion Dose level: 1×10⁹, 3×10⁹, 6×10⁹ cells
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657416
- Sponsor's protocol ID
- NK521-02
- Status last verified
- Sep 2026
- First submitted
- 15 Jun 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NK521 in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07657416
- Acronym / sponsor ID
- NK521-02
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Base Therapeutics (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: Intravenous NK521 Intervention: NK521 Cell Injection Route: Intravenous infusion Dose level: 1×10⁹, 3×10⁹, 6×10⁹ cells Arm 2: Intraperitoneal NK521Intervention: NK521 Cell Injection Route: Intraperitoneal perfusion Dose level: 1×10⁹, 3×10⁹, 6×10⁹ cells
| Arm | Type | Receives |
|---|---|---|
| Intravenous NK521 | Experimental | Biological: NK521 Cell InjectionNK521 Cell Injection Route: Intravenous infusion Dose level: 1×10⁹, 3×10⁹, 6×10⁹ cells |
| Intraperitoneal NK521 | Experimental | Biological: NK521 Cell InjectionNK521 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK521 Cell InjectionGene-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. | Biological | Intravenous NK521 |
| NK521 Cell InjectionGene-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. | Biological | Intraperitoneal NK521 |
Primary outcome
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.
4 secondary outcomes
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.
Progression-Free Survival (PFS)
Time frame: 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.
Malignant Ascites Control Rate
Time frame: From the first intraperitoneal administration, assessed every 3 weeks until the end of treatment, up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Related trials for Hepatocellular Carcinoma (HCC)
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NK521 Cell Injection in people with Hepatocellular Carcinoma (HCC) and Ovarian Cancer, run by Base Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun Beicheng (0551-62923004, ayfykyll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.