Immunoglobulin A Nephropathy (IgAN)Early Phase 1NCT07135219
A Study of Cizutamig in Patients With Immunoglobulin A Nephropathy
A Early Phase 1 study testing Biological: cizutamig in people with Immunoglobulin A Nephropathy (IgAN), run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immunoglobulin A Nephropathy (IgAN)
- What is being tested?
- Biological: cizutamig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2025to Jan 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with IgAN.
Read the 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
- Conditions
- Immunoglobulin A Nephropathy (IgAN)
- Being tested
- Biological: cizutamig
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: cizutamigDrug
Cizutamig will be dosed according to the protocol.
| Study group | Role | What they receive |
|---|---|---|
| A study of cizutamig in patients with immunoglobulin A nephropathy | Experimental | Experlmental: Cizutamig intravenous intervention Receives: Drug: Biological: cizutamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Incidence and severity of TEAEs through end of study：
- Incidence and severity of treatment-emergent adverse events through end of study
- Changes from baseline in vital signs, ECG, and laboratory assessments through end of study
Measured: Baseline up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start16 Jul 2025
- Primary completionDec 2025 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin A Nephropathy (IgAN)Studies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135219
- Sponsor's protocol ID
- CND106-PUFH-1
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07135219
- Acronym / sponsor ID
- CND106-PUFH-1
- Conditions
- Immunoglobulin A Nephropathy (IgAN)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A study of cizutamig in patients with immunoglobulin A nephropathy | Experimental | Drug: Biological: cizutamigExperlmental: Cizutamig intravenous intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological: cizutamigCizutamig will be dosed according to the protocol. | Drug | A study of cizutamig in patients with immunoglobulin A nephropathy |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Baseline up to 52 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Biological: cizutamig in people with Immunoglobulin A Nephropathy (IgAN), run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: Baseline up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.