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.
Must be >=5 years old and <=35 years old at the time of informed consent;
Diagnosed with SLE, with a renal biopsy within the past 24 months (for relapsed patients, biopsy must be after relapse) showing proliferative lupus nephritis (Class III or IV), or proliferative lupus nephritis with Class V (III/IV + V), and still in a moderately to severely active state at screening;
Either newly diagnosed or have shown poor response to current standard treatment after relapse;
Positive for antinuclear antibodies (ANA), and positive for anti-dsDNA or anti-Sm antibodies;
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;
Shanghai Jiao Tong University School of Medicine
Lead sponsor
Asoarx Therapeutics Co., Ltd., Shanghai Branch
Collaborator