A Study of Cizutamig in Patients With Immunoglobulin A Nephropathy

Peking University

Status and phase

Invitation-only

Early Phase 1

Conditions

Immunoglobulin A Nephropathy (IgAN)

Treatments

Drug: Biological: cizutamig

Study type

Interventional

Funder types

Other

Identifiers

NCT07135219

CND106-PUFH-1

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with IgAN.

Full description

An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients with Immunoglobulin A Nephropathy

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.