Status:
ENROLLING_BY_INVITATION
A Study of Cizutamig in Patients With Immunoglobulin A Nephropathy
Lead Sponsor:
Peking University First Hospital
Conditions:
Immunoglobulin A Nephropathy (IgAN)
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
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 Nephropath...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07135219
Start Date
July 16 2025
End Date
January 1 2027
Last Update
August 22 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, China