Phase 1b/2a Prospective, Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects with Immunoglobulin G4-Related Disease

未提供0 个研究点目标入组 4 人开始时间: 待定

适应症

试验速览

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•To be eligible for this study, all of the following inclusion criteria must be met:
•Signed Informed Consent
•Male or female >= 18 to 75 years of age
•Active IgG4-RD flare at screening with IgG4-RD Responder Index at least 2, confirmed by symptoms, labs, and/or imaging.
•History of IgG4-RD involving at least 2 organs/sites, and current flare involves at least 1 organ/site (excluding lymph nodes) requiring treatment.
•Elevated serum IgG4 above the upper limit of normal at screening.
•Able to receive glucocorticoids for current flare and taper to 0 mg by Day -
•Contraception agreement per protocol from screening through 24 weeks after last ACE1831 dose [no lymphodepletion conditionin (LDC)] or 12 months after last LDC dose (with LDC)
•For sites in China only: prior treatment failure to glucocorticoids and at least one immunosuppressive agent.

•An individual who meets any of the following criteria will be excluded from participation in this trial.
•Significant conditions that impair ability to receive study treatment or comply.
•Predominant fibrosis in affected organs.
•Active/latent infection that would interfere with therapy(including HBV, HCV, HIV, TB, syphilis) or significant recent infection per protocol.
•Known immunodeficiency state.
•NYHA class III/IV heart disease.
•Severe allergy/hypersensitivity to monoclonal antibodies or relevant study agents.
•Malignancy within 5 years (protocol exceptions apply).
•Recent investigational agent exposure.
•Recent B-cell depleting therapy (anti-CD20/anti-CD19) unless reconstitution per protocol.
•Live/attenuated vaccine within 2 months.
•Pregnant or breastfeeding.
•Inadequate organ function/blood counts per protocol.

发起方

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