This is an open lable and single arm study designed to evaluate the safety, PK and PD of Arnovie101 in B cell-mediated Autoimmune Disease
Ability to voluntarily sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.
Male or female, aged 18 to 60 years (inclusive) at screening.
Female participants must meet the following criteria: 1) Not pregnant or breastfeeding; 2) Surgically sterile or postmenopausal for ≥2 years, or if of childbearing potential (including those postmenopausal <2 years), have a negative serum pregnancy test (β-hCG) and agree to use effective contraception (e.g., condom, spermicide, or intrauterine device) during the study and for at least 12 months after the last dose. Use of progesterone-only contraceptives is not permitted; 3) Agree not to breastfeed during the study and for at least 12 months after the last dose.
Male participants must meet the following criteria: If not surgically sterile and engaging in sexual activity that could lead to pregnancy, agree to use effective contraception (e.g., condom, spermicide) during the study and for at least 12 months after the last dose, and refrain from donating semen or sperm during the study and for 12 months after the last dose.
Presence of an unresected thymoma.
Pregnant or lactating women.
History of active severe or unstable neuropsychiatric SLE, including but not limited to poorly controlled seizures, psychosis, acute confusional state, cerebrovascular accident, demyelinating syndrome, cranial neuropathy, or active central nervous system vasculitis.
Presence of clinically significant central nervous system disease or pathology before screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/seizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
Single group
Arnovie101 Infusion Intravenous
DrugDosing will begin at a lower dose level and may be escalated to dose levels considered safe and potentially effective according to the study protocol.
Incidence of dose-limiting toxicity (DLT)
Incidence and severity of adverse event (AE) and serious adverse event (SAE)
Change from baseline of SLEDAI-2K score after Arnovie101 administration in participants with relapsed/refractory SLE.
Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline administration at various timepoints up to month 12 follow-up visit. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.
Quantify the clinical activity of Arnovie101 in patients using Physician Global Assessment (PGA) in participants with relapsed/refractory SLE.
Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit. A total score can fall between 0.0 and 3.0, with a higher score representing a more significant degree of disease activity.
Proportion of participants achieving lupus low disease activity status (LLDAS) in participants with relapsed/refractory SLE.
Proportion of participants who achieve LLDAS at scheduled visits through Month 12.
Proportion of patients achieving DORIS remission after Arnovie101 administration in participants with relapsed/refractory SLE.
Assessment of DORIS response rate at various timepoints up to the month 12 follow-up visit.
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Circunited BioPharma (Shenzhen) Co., Ltd.
Lead sponsor
Boji Medical Technology Co., Ltd.
Collaborator
