Biological: cizutamig: Cizutamig will be dosed according to the protocol.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Peking University First Hospital
Beijing
China
More Peking University First Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.