Immunoglobulin A Nephropathy (IgAN)
Conditions
Brief summary
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with IgAN.
Detailed description
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients with Immunoglobulin A Nephropathy
Interventions
Cizutamig will be dosed according to the protocol.
Sponsors
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 75 years of age at the time of signing the informed consent form (ICF). * Biopsy-confirmed IgAN as specified in the protocol. * 24-hour urine protein excretion ≥1.0 g/day or 24-hour urine protein to creatinine ratio (uPCR) ≥0.75 g/g . * Inadequate response to ≥1 of the therapies defined in the protocol. * eGFR \>30 mL/min/1.73m2.
Exclusion criteria
* Inadequate clinical laboratory parameters at Screening. * Receipt of or inability to discontinue any of the following excluded therapies as specified in the protocol. * Receipt of live vaccine within 4 weeks prior to Screening. * MEST-C score of T2 from the Oxford IgAN classification schema. If MEST-scoring was not performed, the presence of \>50% tubular atrophy/interstitial fibrosis is exclusionary. * Rapidly progressing glomerulonephritis with eGFR reduction ≥50% within 12 weeks of Screening. * Secondary IgAN (eg, chronic liver disease, celiac disease, HIV). * History of IgA vasculitis. * Presence of any concomitant autoimmune disease . * History of progressive multifocal leukoencephalopathy. * History of primary immunodeficiency or a hereditary deficiency of the complement system. * Central nervous system (CNS) disease . * Presence of 1 or more significant concurrent medical conditions per investigator judgment. * Diagnosis or history of malignant disease within 5 years prior to Screening. * Tonsillectomy within 24 weeks prior to Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Baseline up to 52 weeks | Incidence and severity of TEAEs through end of study： 1. Incidence and severity of treatment-emergent adverse events through end of study 2. Changes from baseline in vital signs, ECG, and laboratory assessments through end of study |
Countries
China
Outcome results
None listed