NCT07135219Enrolling by invitationEarly phase 1
A Study of Cizutamig in Patients With Immunoglobulin A Nephropathy
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients With Immunoglobulin A Nephropathy
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with IgAN.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 1 Aug 2025
- Start date
- 16 Jul 2025
- Primary completion date
- Dec 2025
- Lead sponsor
- Peking University First Hospital
- Diseases
- IgA nephropathy
- NCT number
- NCT07135219
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 15
- From 16 Jul 2025 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Presence of any concomitant autoimmune disease .
- Presence of 1 or more significant concurrent medical conditions per investigator judgment.
- Tonsillectomy within 24 weeks prior to Screening.
Other illness
- Secondary IgAN (eg, chronic liver disease, celiac disease, HIV).
- History of IgA vasculitis.
- History of progressive multifocal leukoencephalopathy.
- History of primary immunodeficiency or a hereditary deficiency of the complement system.
- Central nervous system (CNS) disease .
- Diagnosis or history of malignant disease within 5 years prior to Screening.
Lab values
- Inadequate clinical laboratory parameters at Screening.
- Rapidly progressing glomerulonephritis with eGFR reduction ≥50% within 12 weeks of Screening.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.