Systemic Lupus Erythenlatosus NephritisEarly Phase 1NCT07412210
Safety and Efficacy of ES-NK Cell Injection in the Treatment of Refractory Lupus Nephritis: an Early Clinical Study
A Early Phase 1 study testing AXA-NK02 in people with Systemic Lupus Erythenlatosus Nephritis, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
This is a single-arm, open-label, dose-escalation clinical trial. The entire trial is preliminarily expected to enroll 5 to 9 subjects. The initial plan is to explore three dose groups: 2.5×10⁷, 7.5×10⁷, and 2.5×10⁸ cells/kg, with 3 subjects in each group. Read more about this study
- Who is it for?
- Ages 5 to 35 years
- Conditions the study is for
- Systemic Lupus Erythenlatosus Nephritis
- What is being tested?
- AXA-NK02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Mar 2029
- 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 5 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- SLE patients in lupus crisis, manifested by rapidly progressive lupus nephritis, diffuse alveolar hemorrhage, thrombotic microangiopathy, neuropsychiatric lupus, diffuse alveolar hemorrhage, pericardial tamponade, lupus mesenteric vascularization inflammation, catastrophic antiphospholipid antibody syndrome;
- Presence of uncontrolled active infection at the time of enrollment, or active viral infection of HBV, HCV or syphilis, etc., or positive HIV screening;
- Uncontrolled diabetes or hypertension, which is judged by the investigator to be unsuitable for immediate enrollment;
- Severe bone marrow dysfunction, severe hepatic cardiopulmonary dysfunction, or severe coagulation dysfunction;
- History of malignancy within the previous 5 years, with the exception of completely resected non-melanoma skin cancer, non-metastatic prostate cancer, and completely cured carcinoma in situ that have been stable for at least 6 months
- Those who are on renal dialysis or are expected to need dialysis during the trial;
Show all 18Show fewer
- Receiving other systemic immunosuppressants other than SLE treatment (topical preparations for skin diseases can be used);
- Received B or T cell targeted therapy before screening, and the B or T cell level is still depleted;
- Previous organ or hematopoietic cell transplantation, or expected transplantation during the trial;
- Those who have received CAR-T cell therapy or gene therapy in the past;
- Immunization (live vaccine) within the week;
- eGFR<=45ml/min/m^2 at screening;
- Abnormal laboratory test indicators, including AST>=3×upper limit of normal (ULN), ALT>=3×ULN, TBIL>=3×ULN, creatinine>220umol/L, ALT/AST>5 times normal value, bilirubin >34umol/L, neutrophil count <1×10^9/L, platelet count <50×10^9/L, hemoglobin <80g/L;
- There are other significant laboratory abnormalities and the investigator believes that the investigation is not suitable for immediate investigational drugs;
- Pregnant or lactating women;
- Contraindications to fludarabine or cyclophosphamide;
- Participated in other clinical studies of investigational drugs or devices within 3 months, or are still within 5 half-lives of clinical trial drugs;
- Presence of other concomitant serious diseases, conditions, or treatments that are assessed by the investigator to pose an unacceptable risk to the subject, or interfere with the subject's study compliance, or interfere with the conduct of the trial, or interfere with the evaluation of efficacy and safety.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Early Clinical Study to Evaluate the Safety and Efficacy of ES-NK Cell Injection in the Treatment of Refractory Lupus Nephritis
This is a single-arm, open-label, dose-escalation clinical trial. The entire trial is preliminarily expected to enroll 5 to 9 subjects.
The initial plan is to explore three dose groups: 2.5×10⁷, 7.5×10⁷, and 2.5×10⁸ cells/kg, with 3 subjects in each group. During the trial, based on a comprehensive assessment by the Safety Review Committee (SRC), the dose, dosing frequency, or dosing interval may be adjusted or increased.
Read more
In the dose-escalation phase, for the same dose group, one subject will be enrolled first. After obtaining at least 4 weeks of safety data, and upon the investigator's assessment confirming that the safety and tolerability risks are controllable, the second and third subjects can be enrolled. If the efficacy and safety data of the first subject in a dose group, based on the investigator's comprehensive judgment, indicate a significantly insufficient pharmacological effect, the study may proceed directly to the next dose group.
Before proceeding to each subsequent dose group, the SRC must evaluate the safety and pharmacodynamic data from the previous dose group for at least 4 weeks. Enrollment for the next group can only begin after the SRC confirms that the safety and tolerability risks are controllable and that the next dose level remains appropriate. The dose escalation will be determined based on safety data, combined with pharmacodynamic and efficacy data.
- Conditions
- Systemic Lupus Erythenlatosus Nephritis
- Being tested
- AXA-NK02
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXA-NK02Biological
Off-the-shelf NK cell products derived from human embryonic stem cells (hESCs)
| Study group | Role | What they receive |
|---|---|---|
| AXA-NK02 | Experimental | Up to three sequential AXA-NK02 dose levels （2.5e7、7.5e7、2.5e8 CAR-NK cells/kg）are planned. Each subject will accept four doses of AXA-NK02 Receives: Biological: AXA-NK02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
SLE remission ratio
Measured: through study completion, an average of 2 year
Ratio of complete/partial remissions in kidney
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythenlatosus NephritisStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Asoarx Therapeutics Co., Ltd., Shanghai Branch
- Responsible party
- Principal investigator, Lei Yin, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412210
- Sponsor's protocol ID
- VGO-Cs01p-002
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with other researchers when AXA-NK02 is fully approved.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Clinical Study to Evaluate the Safety and Efficacy of ES-NK Cell Injection in the Treatment of Refractory Lupus Nephritis
- ClinicalTrials.gov ID
- NCT07412210
- Acronym / sponsor ID
- VGO-Cs01p-002
- Conditions
- Systemic Lupus Erythenlatosus Nephritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Asoarx Therapeutics Co., Ltd., Shanghai Branch
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 17 Feb 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.
This is a single-arm, open-label, dose-escalation clinical trial. The entire trial is preliminarily expected to enroll 5 to 9 subjects.
The initial plan is to explore three dose groups: 2.5×10⁷, 7.5×10⁷, and 2.5×10⁸ cells/kg, with 3 subjects in each group. During the trial, based on a comprehensive assessment by the Safety Review Committee (SRC), the dose, dosing frequency, or dosing interval may be adjusted or increased.
In the dose-escalation phase, for the same dose group, one subject will be enrolled first. After obtaining at least 4 weeks of safety data, and upon the investigator's assessment confirming that the safety and tolerability risks are controllable, the second and third subjects can be enrolled. If the efficacy and safety data of the first subject in a dose group, based on the investigator's comprehensive judgment, indicate a significantly insufficient pharmacological effect, the study may proceed directly to the next dose group.
Before proceeding to each subsequent dose group, the SRC must evaluate the safety and pharmacodynamic data from the previous dose group for at least 4 weeks. Enrollment for the next group can only begin after the SRC confirms that the safety and tolerability risks are controllable and that the next dose level remains appropriate. The dose escalation will be determined based on safety data, combined with pharmacodynamic and efficacy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AXA-NK02 | Experimental | Biological: AXA-NK02Up to three sequential AXA-NK02 dose levels （2.5e7、7.5e7、2.5e8 CAR-NK cells/kg）are planned. Each subject will accept four doses of AXA-NK02 |
Who may qualify
- Ages
- 5 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- SLE patients in lupus crisis, manifested by rapidly progressive lupus nephritis, diffuse alveolar hemorrhage, thrombotic microangiopathy, neuropsychiatric lupus, diffuse alveolar hemorrhage, pericardial tamponade, lupus mesenteric vascularization inflammation, catastrophic antiphospholipid antibody syndrome;
- Presence of uncontrolled active infection at the time of enrollment, or active viral infection of HBV, HCV or syphilis, etc., or positive HIV screening;
- Uncontrolled diabetes or hypertension, which is judged by the investigator to be unsuitable for immediate enrollment;
- Severe bone marrow dysfunction, severe hepatic cardiopulmonary dysfunction, or severe coagulation dysfunction;
- History of malignancy within the previous 5 years, with the exception of completely resected non-melanoma skin cancer, non-metastatic prostate cancer, and completely cured carcinoma in situ that have been stable for at least 6 months
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 |
|---|---|---|
| AXA-NK02Off-the-shelf NK cell products derived from human embryonic stem cells (hESCs) | Biological | AXA-NK02 |
Primary outcome
Incidence and severity of Adverse Events
Time frame: through study completion, an average of 2 year
2 secondary outcomes
SLE remission ratio
Time frame: through study completion, an average of 2 year
Ratio of complete/partial remissions in kidney
Time frame: through study completion, an average of 2 year
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 2 Mar 2026.
- Individual participant dataSharing planned: Yes. IPD will be shared with other researchers when AXA-NK02 is fully approved.
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AXA-NK02 in people with Systemic Lupus Erythenlatosus Nephritis, run by Shanghai Jiao Tong University School of Medicine.
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 0 inclusion and 18 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Lei Yin (13641673203, yinlei@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (time frame: through study completion, an average of 2 year). 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 2 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.