Safety and Efficacy of ES-NK Cell Injection in the Treatment of Refractory Lupus Nephritis: an Early Clinical Study
Starting soon · Early Phase 1
Conditions studied: Systemic Lupus Erythenlatosus Nephritis
In brief
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.
Key facts
- Study ID
- NCT07412210
- Run by
- Shanghai Jiao Tong University School of Medicine
- People needed
- 9
- Starts
- 2026-04-01
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-03-02
Who can join
Age: 5 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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;
- 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.
Full record on ClinicalTrials.gov
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