Advanced Solid TumorsEarly Phase 1NCT07561437
NK521 in the Treatment of Malignant Ascites Associated With Advanced Solid Tumors
A Early Phase 1 study testing NK521 Cell Injection in people with Advanced Solid Tumors, run by Base Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
Study Population: Adult subjects aged 18-75 years with relapsed/refractory advanced solid tumors (including liver, gastric, colorectal, ovarian cancer, etc.) and malignant ascites confirmed by cytology, who have failed at least 2 lines of standard systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- 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
- 9 Mar 2026to Oct 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically diagnosed with relapsed/refractory advanced solid tumors, including but not limited to liver cancer, gastric cancer, colorectal cancer, ovarian cancer, etc.
- Complicated with malignant ascites with identifiable tumor cells in ascites. Patients with advanced solid tumors who have failed at least 2 lines 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.
- All toxicities from prior antineoplastic therapy have resolved to Grade 1 (CTCAE v5.0) or baseline except alopecia and fatigue; subjects with long-term stable sequelae from prior therapy (e.g., platinum-induced neuropathy) are allowed.
Show all 9Show fewer
- 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 other malignancies within the past 3 years.
- Active, known or suspected autoimmune disease, excluding hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia), or diseases not expected to relapse without external triggers.
- 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.
Show all 21Show fewer
- Not fully recovered from major surgery or trauma within 2 weeks before enrollment.
- -Participated in another investigational drug trial and received investigational therapy or used an investigational device within 4 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:
- HBsAg positive with positive HBV-DNA titer or above upper limit of normal (ULN);
- HCV antibody positive.
- Known hypersensitivity or intolerance to PD-1 monoclonal antibody.
- Meeting any of the following laboratory criteria:
- Hematology: Absolute neutrophil count <1.5×10⁹/L; platelet count <75×10⁹/L; hemoglobin <90 g/L.
- 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.
- Renal function: Serum creatinine >1.5×ULN or creatinine clearance <50 mL/min.
- Any uncertain factors affecting subject safety or compliance.
- 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, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 010
Li Ning, 0316-5918495, Ifcancergep@163.com
About this study
Study Population: Adult subjects aged 18-75 years with relapsed/refractory advanced solid tumors (including liver, gastric, colorectal, ovarian cancer, etc.) and malignant ascites confirmed by cytology, who have failed at least 2 lines of standard systemic therapy.
Study Design: This is a dose-escalation, single-center, open-label, prospective Phase 1 study. A total of 18 subjects will be enrolled and assigned to 2 administration groups (9 subjects each):
Read more
Group A (Intravenous infusion): For subjects with small-volume malignant ascites.
Group B (Intraperitoneal perfusion): For subjects with large-volume symptomatic malignant ascites.
Each group will follow a conventional "3+3" dose-escalation design with 3 dose levels (1×10⁹, 3×10⁹, 6×10⁹ NK cells per dose), administered once weekly, 3 weeks per cycle, for 2 consecutive cycles.
Primary Objectives: To evaluate the safety and tolerability, and to determine the dose-limiting toxicity (DLT) of NK521 administered intravenously and intraperitoneally.
Secondary Objectives: To assess the preliminary anti-tumor efficacy including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), puncture-free survival (PuFS), and changes in tumor markers, as well as health-related quality of life (HRQoL).
- Conditions
- Advanced Solid Tumors
- Being tested
- NK521 Cell Injection
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous NK521 | Experimental | Intervention: NK521 Cell Injection Route: Intravenous infusion Dose: 1×10⁹, 3×10⁹, 6×10⁹ cells Receives: Biological: NK521 Cell Injection |
| Intraperitoneal NK521 | Experimental | Intervention: 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 posted1 May 2026
- Study start9 Mar 2026
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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: 1×10⁹, 3×10⁹, 6×10⁹ cells Arm 2: Intraperitoneal NK521 Intervention: NK521 Cell Injection Route: Intraperitoneal perfusion Dose: 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
- NCT07561437
- Sponsor's protocol ID
- NK521-01
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NK521 in the Treatment of Malignant Ascites Associated With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07561437
- Acronym / sponsor ID
- NK521-01
- Conditions
- Advanced Solid Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Base Therapeutics (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 1 May 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.
Study Population: Adult subjects aged 18-75 years with relapsed/refractory advanced solid tumors (including liver, gastric, colorectal, ovarian cancer, etc.) and malignant ascites confirmed by cytology, who have failed at least 2 lines of standard systemic therapy.
Study Design: This is a dose-escalation, single-center, open-label, prospective Phase 1 study. A total of 18 subjects will be enrolled and assigned to 2 administration groups (9 subjects each):
Group A (Intravenous infusion): For subjects with small-volume malignant ascites.
Group B (Intraperitoneal perfusion): For subjects with large-volume symptomatic malignant ascites.
Each group will follow a conventional "3+3" dose-escalation design with 3 dose levels (1×10⁹, 3×10⁹, 6×10⁹ NK cells per dose), administered once weekly, 3 weeks per cycle, for 2 consecutive cycles.
Primary Objectives: To evaluate the safety and tolerability, and to determine the dose-limiting toxicity (DLT) of NK521 administered intravenously and intraperitoneally.
Secondary Objectives: To assess the preliminary anti-tumor efficacy including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), puncture-free survival (PuFS), and changes in tumor markers, as well as health-related quality of life (HRQoL).
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: 1×10⁹, 3×10⁹, 6×10⁹ cells Arm 2: Intraperitoneal NK521 Intervention: NK521 Cell Injection Route: Intraperitoneal perfusion Dose: 1×10⁹, 3×10⁹, 6×10⁹ cells
| Arm | Type | Receives |
|---|---|---|
| Intravenous NK521 | Experimental | Biological: NK521 Cell InjectionIntervention: NK521 Cell Injection Route: Intravenous infusion Dose: 1×10⁹, 3×10⁹, 6×10⁹ cells |
| Intraperitoneal NK521 | Experimental | Biological: NK521 Cell InjectionIntervention: 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologically diagnosed with relapsed/refractory advanced solid tumors, including but not limited to liver cancer, gastric cancer, colorectal cancer, ovarian cancer, etc.
- Complicated with malignant ascites with identifiable tumor cells in ascites. Patients with advanced solid tumors who have failed at least 2 lines 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 (21 listed)
- Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis.
- History of other malignancies within the past 3 years.
- Active, known or suspected autoimmune disease, excluding hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia), or diseases not expected to relapse without external triggers.
- 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.
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 | Intraperitoneal NK521, Intravenous 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 1 May 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell 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 Advanced Solid Tumors, 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 9 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 1 May 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 1 May 2026.