A Study of Cizutamig in Patients With Immunoglobulin A Nephropathy

NCT07135219 | Enrolling By Invitation Early Phase 1

• 1 other identifier: CND106-PUFH-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunoglobulin A Nephropathy (IgAN)

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  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

  Baseline up to 52 weeks

Study Arms (1)

A study of cizutamig in patients with immunoglobulin A nephropathy

EXPERIMENTAL

Experlmental: Cizutamig intravenous intervention

Drug: Biological: cizutamig

Interventions

Biological: cizutamig DRUG

Cizutamig will be dosed according to the protocol.

A study of cizutamig in patients with immunoglobulin A nephropathy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years of age at the time of signing the informed consent form (ICF).
• Biopsy-confirmed IgAN as specified in the protocol.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 22, 2025
• Study Start: July 16, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)