Refractory Systemic Lupus ErythematosusPhase 1NCT06676631
NK010 or NK042 in Combination With Rituximab for Refractory Systemic Lupus Erythematosus/Lupus Nephritis
A Phase 1 study testing NK 010 or NK042 and Rituximab in people with Refractory Systemic Lupus Erythematosus and Refractory Lupus Nephritis, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK010 or NK042 in combination with rituximab (RTX) for the treatment of patients with refractory systemic lupus erythematosus (SLE) or lupus nephritis (LN) in China. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Refractory Systemic Lupus Erythematosus, Refractory Lupus Nephritis
- What is being tested?
- NK 010 or NK042 and Rituximab
- 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
- 19 Feb 2025to 31 Dec 2027
- Phase
- 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
- 18 to 65 years old, male or female.
- A diagnosis of SLE according to the 2019 EULAR (European League Against Rheumatism)/ACR (American College of Rheumatology).
- Inclusion criteria applicable to the LN subgroup: active type III or IV lupus nephritis (with or without type V) confirmed by renal biopsy according to the 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. An activity index ≥2 and a chronicity index no more than moderate according to the 2018 RPS Task Force for LN pathologic types and the National Institutes of Health (NIH) Lupus Nephritis Activity and Chronicity Index Score criteria. Urine protein/creatinine ratio (UPCR) ≥ 1.0 g/g or 24-hour urine protein quantification ≥ 1.0 g/day.
- One of the following at screening: positive antinuclear antibody (ANA) OR positive anti-dsDNA OR positive anti-Smith antibody.
- SLEDAI-2000 score ≥ 8.
- Prior to screening, having received glucocorticoids combined with immunosuppressants and/or biologics for at least 3 months with stable doses for >2 weeks, but disease still active (i.e., received glucocorticoids + immunosuppressants or glucocorticoids + immunosuppressants + biologics; monotherapy with any of the above drugs is not eligible).
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- Hematologic, hepatic, renal, pulmonary, and cardiac function criteria at screening were as follows: ① leukocytes ≥ 2 ×109/L and lymphocyte count ≥ 0.5 ×109 /L; ② serum ALT and AST ≤ 3 times the upper limit of normal; ③ total bilirubin ≤ 1.5 times the upper limit of normal, with the exception of patients with Gilbert's syndrome, for whom total bilirubin was ≤ 3.0 times the upper limit of normal; ④ eGFR (based on the creatinine based on the CKD-EPI formula) ≥ 30 ml/min/1.73m2; ⑤ oxygen saturation ≥ 92% in non-oxygenated state under indoor ventilation; no clinically significant pleural effusion; ⑥ left ventricular ejection fraction ≥ 45%, and no clinically significant abnormal findings on ECG.
- For participants not receiving therapeutic anticoagulation: International standardized ratio (INR) ≤ 1.5 times the upper limit of normal, or prothrombin time (PT) ≤ 1.5 times the upper limit of normal.
- Participants receiving hematopoietic growth factor support therapy, including erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage-colony-stimulating factor (GM-CSF), and platelet agonists (TPO), must have a 2-week interval between the last growth factor support therapy and the screening period assessment; those receiving blood product transfusion that require at least 1 week between the screening period platelet assessment and the last platelet transfusion, and at least 2 weeks between the screening period hemoglobin assessment and the last red blood cell transfusion.
- Female participants of childbearing potential must have a negative serum pregnancy test at screening (women who are surgically sterilized or have been menopausal for at least 2 years are not considered to be of childbearing potential). Female subjects of childbearing potential and male subjects must use highly effective methods of contraception throughout the clinical study and for 1 year after the last study treatment; they should also commit not to donate eggs (oocytes, oocytes)/sperm for assisted reproduction for 1 year after the last study treatment.
- Participants are willing to participate in this study and sign a paper version of the informed consent form.
Who cannot join
- Requires dialysis treatment (hemodialysis or peritoneal dialysis) at the time of screening or is expected to require dialysis treatment during study treatment.
- Have received a solid organ or hematopoietic cell transplant or plan to do so during study period.
- Have a congenital or acquired immunodeficiency that results in a serious infection, or are receiving chronic immunoglobulin replacement therapy.
- Presence of active mixed connective tissue or systemic sclerosis, an overlapping syndrome, in the 12 months prior to or during screening, and the adverse condition or other treatment may affect study efficacy or safety assessment or outcomes. Overlapping syndromes in which the anticipated condition or treatment does not affect the assessment or outcome are not excluded.
- Receipt of any B-cell depletion therapy (e.g., anti-CD20, anti-CD19 monoclonal antibody), including but not limited to zolmitriptan in rituximab, obinutuzumab, bortezomib, within 6 months prior to screening; or treatment with any biologic, such as, but not limited to, belimumab, anifrolumab, or tetracycline, within 1 month prior to screening.
- Participants with known anaphylaxis, hypersensitivity, intolerance, or contraindication to NK010 Cell Injection, NK042 Cell Injection, RTX, or any of the components of the drugs that may be used in the study, or subjects who have had a previous severe allergic reaction.
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- Clinically significant central nervous system disease or pathological changes not due to lupus within 3 months prior to the first dose, including, but not limited to, cerebrovascular accident (ischemia/hemorrhage), aneurysm, epilepsy, convulsions/convulsions, aphasia, severe brain injury, dementia, parkinson's disease, cerebellar disorders, organic brain syndromes, or psychiatric disorders.
- Unstable cardiovascular function: ① Uncontrollable angina pectoris or life-threatening unstable arrhythmia; ② Myocardial infarction or unstable angina pectoris within 3 months prior to the screening; ③ Previous coronary artery or graft revascularization; ④ Uncontrolled, clinically significant arrhythmia (e.g., sustained ventricular tachycardia, ventricular fibrillation, tip-twisting); ⑤ Mobitz type II Mobitz type II or III atrioventricular block; (6) congestive heart failure or severe cardiac insufficiency with New York Heart Association classification ≥ grade 3; (7) prolongation of the QT interval (QTc) corrected for heart rate (Fridericia) by > 480 milliseconds; (8) uncontrolled hypertension (systolic blood pressure >160 mm Hg and/or diastolic blood pressure > 100 mm Hg), or associated with hypertensive crisis or hypertensive encephalopathy.
- Active bleeding.
- Any active infection, excluding fungal infections of the nail beds; history of severe recurrent or chronic infections.
- Presence of active infection treated with intravenous antibiotics within 14 days prior to screening, except for antibiotic prophylaxis (including intravenous administration).
- Positive serum HIV viral antibodies or history of active HIV infection and positive syphilis antibodies at screening.
- Positive Hepatitis B Surface Antigen (HBsAg). Participants who are HBsAg negative and Hepatitis B Core Antibody (HBcAb) positive, but Hepatitis B Virus (HBV) DNA negative are eligible for enrollment, but will require monitoring of HBV DNA at each follow-up visit.
- Positive Hepatitis C Serology. Participants with hepatitis C antibodies positive but do not have detectable hepatitis C virus (HCV) RNA for at least 6 months after completion of antiviral therapy are eligible for enrollment, but require monitoring of HCV RNA at each follow-up visit.
- Risk of active tuberculosis at screening, with or without completion of adequate treatment, including the presence of signs or symptoms of active tuberculosis (e.g., fever, cough, night sweats, and weight loss) as judged by the investigator at screening; documented active tuberculosis on chest imaging (e.g., chest x-ray, chest CT scan) performed at screening or at any time during the 6 months prior to screening; latent tuberculosis at screening evidence of infection such as a positive gamma-interferon release test.
- Participants with a malignant tumor, including tumor-associated polymyositis/dermatomyositis, within 5 years prior to screening. Except for surgically resected and cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, low-stage bladder cancer, ductal carcinoma in situ of the breast, or cured participants with no evidence of recurrence within the last 2 years and no need for treatment.
- Previous received cell therapy such as CAR-T, CAR-NK, ect.
- Pregnant or lactating women, or (if of childbearing potential) subjects who are not using adequate contraception or planning to donate oocytes and sperm.
- The presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the opinion of the Investigator, may affect the safety of the subject or compliance with the study.
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
Guangdong Provincial People's Hospital
Guangzhou, Guangdomg, 510080
Xueqing Yu, yuxueqing@gdph.org.cn
About this study
Official title: NK010 or NK042 Cell Injection in Combination With Rituximab in Patients With Refractory Systemic Lupus Erythematosus or Lupus Nephritis
This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK010 or NK042 in combination with rituximab (RTX) for the treatment of patients with refractory systemic lupus erythematosus (SLE) or lupus nephritis (LN) in China.
Read the detailed description
The study will consist of 3 study periods for each study subject inclusive of screening, treatment and follow-up. During the treatment phase, the subjects will receive 1000 mg of rituximab treatment on day 1, followed by NK010 or NK042 treatment on days 4, 6, and 8, respectively. The subject will be followed at the day 14, day 28, Month 2, Month 3, and every 3 months for 1 year.
- Being tested
- NK 010 or NK042, Rituximab
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK 010 or NK042Biological
Also called NK010 or NK042 infusion
NK010 is an allogeneic non-genetically modified NK cell infusion. NKX010 will be administered at a dose of 2.5 × 109 NK cells, 5.0 × 109 NK cells and 7.5 × 109 NK cells by a dose-escalation design and administered IV. N042 is an allogeneic genetic modification of NK cell. NKX042 will be administered at a dose of 6 × 108 NKR positive NK cells, 1.2 × 109 NKR positive NK cells and 2.4 × 109 NKR positive NK cells by a dose-escalation design and administered IV.
RituximabDrug
Also called RTX
RTX dose of 1 g administered IV over 60 minutes at the first day of the treatment phase.
| Study group | Role | What they receive |
|---|---|---|
| NK 010 or NK 042 infusion | Experimental | Subjects with refractory SLE or LN will receive rituximab followed by NK010 or NK042. Receives: Biological: NK 010 or NK042; Drug: Rituximab |
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: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
Number of participants who achieved renal response
For subjects with LN: evaluate the number of participants achieved complete renal response (CRR) and partial renal response (PRR) according to European Alliance of Associations for Rheumatology (EULAR)/European Renal Association-European Dialysis and Transplantation Association (ERA-EDTA) criteria.
Measured: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
Number of subjects who achieved lupus low disease activity state (LLDAS)
Low lupus disease activity was defined as (i) SLEDAI-2K total score ≤ 4, no active lesions in major organ systems (including kidney, central nervous system, cardiopulmonary, vasculitis, and fever) and no hemolytic anemia or gastrointestinal lesions; (ii) no new indications of lupus disease activity compared with previous evaluations (according to SLEDAI-2K); (iii) Physician's Global Assessment (PGA) ≤ 1; and (iv) prednisone ≤ 7.5 mg d for use of malaria and biologic agents. Assessment (PGA) ≤ 1 point; ④ Prednisone ≤ 7.5 mg/d, maintenance of standard therapy. biologics.
Measured: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
Number of participants who achieved clinical remission of SLE
Clinical remission of SLE was defined by 2021 DORIS SLE remission criteria.
Measured: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
The change of Physician Global Assessment (PGA) score
The change of PGA score will be compared to baseline.
Measured: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
The change of SLEDAI-2000 scores
The change of SLEDAI-2000 score will be compared to baseline.
Measured: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
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, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
Dose-limiting toxicity (DLT) rate
This is to measure the dose-limiting toxicity of NK 010 or NK 042.
Measured: 28 days after initial study treatment.
Incidence of treatment-related adverse events
This is to measure safety and tolerability of NK 010 or NK 042.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start19 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xueqing Yu, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676631
- Sponsor's protocol ID
- NK010-NK042-I-SLE-01
- Status last verified
- Jun 2026
- First submitted
- 5 Nov 2024
- Last updated
- 12 Jun 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NK010 or NK042 Cell Injection in Combination With Rituximab in Patients With Refractory Systemic Lupus Erythematosus or Lupus Nephritis
- ClinicalTrials.gov ID
- NCT06676631
- Acronym / sponsor ID
- NK010-NK042-I-SLE-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Nov 2024 (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 NK010 or NK042 in combination with rituximab (RTX) for the treatment of patients with refractory systemic lupus erythematosus (SLE) or lupus nephritis (LN) in China.
Detailed description
The study will consist of 3 study periods for each study subject inclusive of screening, treatment and follow-up. During the treatment phase, the subjects will receive 1000 mg of rituximab treatment on day 1, followed by NK010 or NK042 treatment on days 4, 6, and 8, respectively. The subject will be followed at the day 14, day 28, Month 2, Month 3, and every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NK 010 or NK 042 infusion | Experimental | Biological: NK 010 or NK042, Drug: RituximabSubjects with refractory SLE or LN will receive rituximab followed by NK010 or NK042. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 to 65 years old, male or female.
- A diagnosis of SLE according to the 2019 EULAR (European League Against Rheumatism)/ACR (American College of Rheumatology).
- Inclusion criteria applicable to the LN subgroup: active type III or IV lupus nephritis (with or without type V) confirmed by renal biopsy according to the 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. An activity index ≥2 and a chronicity index no more than moderate according to the 2018 RPS Task Force for LN pathologic types and the National Institutes of Health (NIH) Lupus Nephritis Activity and Chronicity Index Score criteria. Urine protein/creatinine ratio (UPCR) ≥ 1.0 g/g or 24-hour urine protein quantification ≥ 1.0 g/day.
- One of the following at screening: positive antinuclear antibody (ANA) OR positive anti-dsDNA OR positive anti-Smith antibody.
- SLEDAI-2000 score ≥ 8.
Key exclusion criteria (19 listed)
- Requires dialysis treatment (hemodialysis or peritoneal dialysis) at the time of screening or is expected to require dialysis treatment during study treatment.
- Have received a solid organ or hematopoietic cell transplant or plan to do so during study period.
- Have a congenital or acquired immunodeficiency that results in a serious infection, or are receiving chronic immunoglobulin replacement therapy.
- Presence of active mixed connective tissue or systemic sclerosis, an overlapping syndrome, in the 12 months prior to or during screening, and the adverse condition or other treatment may affect study efficacy or safety assessment or outcomes. Overlapping syndromes in which the anticipated condition or treatment does not affect the assessment or outcome are not excluded.
- Receipt of any B-cell depletion therapy (e.g., anti-CD20, anti-CD19 monoclonal antibody), including but not limited to zolmitriptan in rituximab, obinutuzumab, bortezomib, within 6 months prior to screening; or treatment with any biologic, such as, but not limited to, belimumab, anifrolumab, or tetracycline, within 1 month prior to screening.
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 |
|---|---|---|
| NK 010 or NK042Also: NK010 or NK042 infusionNK010 is an allogeneic non-genetically modified NK cell infusion. NKX010 will be administered at a dose of 2.5 × 109 NK cells, 5.0 × 109 NK cells and 7.5 × 109 NK cells by a dose-escalation design and administered IV. N042 is an allogeneic genetic modification of NK cell. NKX042 will be administered at a dose of 6 × 108 NKR positive NK cells, 1.2 × 109 NKR positive NK cells and 2.4 × 109 NKR positive NK cells by a dose-escalation design and administered IV. | Biological | NK 010 or NK 042 infusion |
| RituximabAlso: RTXRTX dose of 1 g administered IV over 60 minutes at the first day of the treatment phase. | Drug | NK 010 or NK 042 infusion |
Primary outcome
Response rate for SLE response index 4 (SRI4)
Time frame: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
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).
Number of participants who achieved renal response
Time frame: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
For subjects with LN: evaluate the number of participants achieved complete renal response (CRR) and partial renal response (PRR) according to European Alliance of Associations for Rheumatology (EULAR)/European Renal Association-European Dialysis and Transplantation Association (ERA-EDTA) criteria.
Number of subjects who achieved lupus low disease activity state (LLDAS)
Time frame: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
Low lupus disease activity was defined as (i) SLEDAI-2K total score ≤ 4, no active lesions in major organ systems (including kidney, central nervous system, cardiopulmonary, vasculitis, and fever) and no hemolytic anemia or gastrointestinal lesions; (ii) no new indications of lupus disease activity compared with previous evaluations (according to SLEDAI-2K); (iii) Physician's Global Assessment (PGA) ≤ 1; and (iv) prednisone ≤ 7.5 mg d for use of malaria and biologic agents. Assessment (PGA) ≤ 1 point; ④ Prednisone ≤ 7.5 mg/d, maintenance of standard therapy. biologics.
Number of participants who achieved clinical remission of SLE
Time frame: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
Clinical remission of SLE was defined by 2021 DORIS SLE remission criteria.
The change of Physician Global Assessment (PGA) score
Time frame: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
The change of PGA score will be compared to baseline.
The change of SLEDAI-2000 scores
Time frame: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
The change of SLEDAI-2000 score will be compared to baseline.
Changes of autoantibody of SLE from baseline
Time frame: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion
Autoantibody include anti-dsDNA, anti-nuclear antibody, ANA, anti-Sm antibody, and complement C3, C4.
Dose-limiting toxicity (DLT) rate
Time frame: 28 days after initial study treatment.
This is to measure the dose-limiting toxicity of NK 010 or NK 042.
Incidence of treatment-related adverse events
Time frame: 1 year
This is to measure safety and tolerability of NK 010 or NK 042.
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 12 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Xueqing Yu principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NK 010 or NK042 and Rituximab in people with Refractory Systemic Lupus Erythematosus and Refractory Lupus Nephritis, run by Guangdong Provincial People's Hospital 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 11 inclusion and 19 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 12 Jun 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xueqing Yu, Ph.D (8620-83827897, yuxueqing@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate for SLE response index 4 (SRI4) (time frame: Day 14, day 28, 2 months, 3 months, 6 months, 9 months, 12 months after the first administration of NK010 or NK042 infusion). The study lists 9 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 12 Jun 2026.