A Study of Cizutamig in Patients With Immunoglobulin A Nephropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological: cizutamig.
- Who it may be relevant to
- Registry conditions: Immunoglobulin A Nephropathy (IgAN). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients With Immunoglobulin A Nephropathy
Overview
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
- Drug Biological: cizutamig
Cizutamig will be dosed according to the protocol.
Primary outcome measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Baseline up to 52 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT07135219 · CND106-PUFH-1