Refractory Systemic Lupus ErythematosusEarly Phase 1NCT07083349
NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus
A Early Phase 1 study testing NK510 : allogeneic genetic modified NK in people with Refractory Systemic Lupus Erythematosus, run by Base Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK510 for the treatment of patients with refractory systemic lupus erythematosus (SLE) in China. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Systemic Lupus Erythematosus
- What is being tested?
- NK510 : allogeneic genetic modified NK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Apr 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years old, male or female.
- A diagnosis of SLE according to the 2019 EULAR (European League Against Rheumatism)/ACR (American College of Rheumatology).
- The subject voluntarily participates in this clinical study and signs the Informed Consent Form (ICF).
- Before screening, the subject must have received glucocorticoid combined with immunosuppressants and/or biological agents for at least 2 months, with a stable dose for more than 2 weeks, but the disease remains active; within 7 days before lymphodepleting conditioning, the blood routine test must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; hemoglobin (Hb) ≥ 80g/L; platelet count (PLT) ≥ 50×10⁹/L.
- SLEDAI-2K score > 8 points at screening.
- Antinuclear antibody (ANA) ≥ 1:80 at screening.
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- Having appropriate organ functions:
- Liver function: aspartate transaminase (AST) ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3 times ULN; total bilirubin ≤ 1.5 times ULN, unless the subject has a record of Gilbert syndrome; subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN can be included;
- Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60 mL/min;
- Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; absolute lymphocyte count (ALC) ≥ 0.1×10⁹/L; hemoglobin (Hb) ≥ 80 g/L; platelet count (PLT) ≥ 50×10⁹/L.
- Women of childbearing age must be non-lactating and have a negative serum pregnancy test within 1 week before administration. In addition, all subjects (whether male or female) must agree to use contraception during the period of NK510 treatment starting from enrollment and within 3 months after the end of treatment.
- Able to comply with the study protocol and follow-up procedures.
Who cannot join
- Patients with active lupus nephritis.
- Those with allergies to the study drug or other medications used in the study protocol.
- Those with any of the following conditions: ① Having received autologous/allogeneic hematopoietic stem cell transplantation within 3 months; ② Having received ultraviolet irradiation therapy within 6 weeks; ③ Having received biologic agent therapy (excluding other medications used in the study protocol) within 4 weeks or 3 half-lives (whichever is longer); ④ Having undergone major surgery or received live vaccines within 4 weeks; ⑤ Having received experimental treatment (except for definite placebo control groups) within 4 weeks.
- Those with other active, known, or suspected autoimmune diseases.
- Presence of uncontrolled active bacterial, viral, fungal, mycobacterial, or other infections requiring treatment with intravenous antibiotics, antiviral drugs, or antifungal drugs within 14 days before lymphodepleting conditioning; however, prophylactic use of these drugs (including intravenous administration) is allowed.
- History of immunodeficiency, including positive HIV test results, or other acquired/congenital immunodeficiency diseases, or history of organ transplantation.
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- History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.); QTc interval > 480 ms on 12-lead electrocardiogram at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before administration; New York Heart Association (NYHA) cardiac function class ≥ II or left ventricular ejection fraction (LVEF) < 50%.
- Failure to fully recover from major surgery or trauma within 2 weeks before administration.
- History of malignant tumors.
- Screening results of hepatitis B or C virological tests meeting any of the following:
- HBsAg positive, and peripheral blood HBV-DNA titer ≥ 1×10³ copies/mL or upper limit of normal;
- Anti-HCV positive.
- Those deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
About this study
Official title: An Open, Single-Center Exploratory Clinical Study of NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus
This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK510 for the treatment of patients with refractory systemic lupus erythematosus (SLE) in China.
- Conditions
- Refractory Systemic Lupus Erythematosus
- Being tested
- NK510 : allogeneic genetic modified NK
- Keywords
- SLE
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK510 : allogeneic genetic modified NKDrug
NK510 is an allogeneic genetic modification of NK cell. NK510 will be administered at a dose of 4x10^7 NK/kg, 8x10^7 NK/kg and 1.2x10^8 NK/kg by a dose-escalation design and administered IV.
| Study group | Role | What they receive |
|---|---|---|
| NK510 infusion | Experimental | NK510 Receives: Drug: NK510 : allogeneic genetic modified NK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate for SLE response index 4 (SRI4)
SRI4 response defined as a reduction of ≥4 points on SLEDAI-2000, no new domain A scores and no more than 1 new domain B score on BILAG 2004, and no deterioration in PGA (<0.3 point increase).
Measured: 3 months, 6 months after the first administration of NK510
Incidence of treatment-related adverse events
This is to measure safety and tolerability of NK510
Measured: 1 year
Dose-limiting toxicity (DLT) rate
This is to measure the dose-limiting toxicity of NK510
Measured: 28 days after initial study treatment.
Secondary outcomes (4)
Number of subjects who achieved lupus low disease activity state (LLDAS)
Low lupus disease activity was defined as SLEDAI-2K ≤ 4 points; no major organ system activity, no active hemolytic anemia or gastrointestinal involvement, and no new disease activity manifestations compared with the previous disease assessment; PGA score ≤ 1 point, daily prednisone equivalent dose ≤ 7.5 mg/day, with the permission of using maintenance doses of antimalarials and immunosuppressants (including biological agents).
Measured: 3 months, 6 months after the first administration of NK510
Number of participants who achieved clinical remission of SLE
Clinical remission of SLE was defined by DORIS SLE remission criteria.
Measured: 3 months, 6 months after the first administration of NK510
The change of SLEDAI-2000(Systemic lupus erythematosus disease activity index 2000) scores
The change of SLEDAI-2000 score (from 0 to 105 points) will be compared to baseline.
Measured: Day 28, 3 months, 6 months after the first administration of NK510
Changes of autoantibody of SLE from baseline
Autoantibody include anti-dsDNA, anti-nuclear antibody, ANA, anti-Sm antibody, and complement C3, C4.
Measured: Day 14, 3 months, 6 months after the first administration of NK510
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Dec 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Systemic Lupus ErythematosusStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- NK510 is an allogeneic genetically modified NK cell infusion.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083349
- Sponsor's protocol ID
- NK510-14
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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
- An Open, Single-Center Exploratory Clinical Study of NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07083349
- Acronym / sponsor ID
- NK510-14
- Conditions
- Refractory Systemic Lupus Erythematosus
- Keywords
- SLE
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Base Therapeutics (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 24 Jul 2025 (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.
This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK510 for the treatment of patients with refractory systemic lupus erythematosus (SLE) in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- NK510 is an allogeneic genetically modified NK cell infusion.
| Arm | Type | Receives |
|---|---|---|
| NK510 infusion | Experimental | Drug: NK510 : allogeneic genetic modified NKNK510 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18 to 70 years old, male or female.
- A diagnosis of SLE according to the 2019 EULAR (European League Against Rheumatism)/ACR (American College of Rheumatology).
- The subject voluntarily participates in this clinical study and signs the Informed Consent Form (ICF).
- Before screening, the subject must have received glucocorticoid combined with immunosuppressants and/or biological agents for at least 2 months, with a stable dose for more than 2 weeks, but the disease remains active; within 7 days before lymphodepleting conditioning, the blood routine test must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; hemoglobin (Hb) ≥ 80g/L; platelet count (PLT) ≥ 50×10⁹/L.
- SLEDAI-2K score > 8 points at screening.
Key exclusion criteria (13 listed)
- Patients with active lupus nephritis.
- Those with allergies to the study drug or other medications used in the study protocol.
- Those with any of the following conditions: ① Having received autologous/allogeneic hematopoietic stem cell transplantation within 3 months; ② Having received ultraviolet irradiation therapy within 6 weeks; ③ Having received biologic agent therapy (excluding other medications used in the study protocol) within 4 weeks or 3 half-lives (whichever is longer); ④ Having undergone major surgery or received live vaccines within 4 weeks; ⑤ Having received experimental treatment (except for definite placebo control groups) within 4 weeks.
- Those with other active, known, or suspected autoimmune diseases.
- Presence of uncontrolled active bacterial, viral, fungal, mycobacterial, or other infections requiring treatment with intravenous antibiotics, antiviral drugs, or antifungal drugs within 14 days before lymphodepleting conditioning; however, prophylactic use of these drugs (including intravenous administration) is allowed.
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 |
|---|---|---|
| NK510 : allogeneic genetic modified NKNK510 is an allogeneic genetic modification of NK cell. NK510 will be administered at a dose of 4x10^7 NK/kg, 8x10^7 NK/kg and 1.2x10^8 NK/kg by a dose-escalation design and administered IV. | Drug | NK510 infusion |
Primary outcome
Response rate for SLE response index 4 (SRI4)
Time frame: 3 months, 6 months after the first administration of NK510
SRI4 response defined as a reduction of ≥4 points on SLEDAI-2000, no new domain A scores and no more than 1 new domain B score on BILAG 2004, and no deterioration in PGA (<0.3 point increase).
Incidence of treatment-related adverse events
Time frame: 1 year
This is to measure safety and tolerability of NK510
Dose-limiting toxicity (DLT) rate
Time frame: 28 days after initial study treatment.
This is to measure the dose-limiting toxicity of NK510
4 secondary outcomes
Number of subjects who achieved lupus low disease activity state (LLDAS)
Time frame: 3 months, 6 months after the first administration of NK510
Number of participants who achieved clinical remission of SLE
Time frame: 3 months, 6 months after the first administration of NK510
The change of SLEDAI-2000(Systemic lupus erythematosus disease activity index 2000) scores
Time frame: Day 28, 3 months, 6 months after the first administration of NK510
Changes of autoantibody of SLE from baseline
Time frame: Day 14, 3 months, 6 months after the first administration of NK510
Results and safety
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 NK510 : allogeneic genetic modified NK in people with Refractory Systemic Lupus Erythematosus, 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 12 inclusion and 13 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: stopped early, 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?
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate for SLE response index 4 (SRI4) (time frame: 3 months, 6 months after the first administration of NK510). The study lists 3 primary outcomes in all. 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.