Primary Membranous NephropathyPhase 1NCT06982729
Study of YK012 in Primary Membranous Nephropathy
A Phase 1 study testing YK012 in people with Primary Membranous Nephropathy, run by Excyte Biopharma Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YK012 in participants with primary membranous nephropathy (PMN). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- YK012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2025to Dec 2027
- Phase
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years (inclusive), regardless of gender.
- Kidney biopsy-confirmed diagnosis of primary (idiopathic) membranous nephropathy within the past 10 years.
- Elevated 24-hour urine protein, meeting the pre-defined criteria.
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m² as calculated by the CKD-EPI equation.
- If currently taking an angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or sodium-glucose cotransporter-2 (SGLT-2) inhibitor, the dose must have been stable for at least 4 weeks prior to enrollment or since initiation of therapy.
- Laboratory test results must meet the predefined criteria within 7 days prior to enrollment.
- Capable of understanding and voluntarily participating in this clinical trial, having provided written informed consent, and able to comply with scheduled visits, treatments, examinations, and other study procedures as required.
Who cannot join
- Diagnosis of secondary membranous nephropathy.
- Any prior receipt of protocol-specified pharmacological treatment for membranous nephropathy.
- History of malignancy within 5 years prior to enrollment.
- Poorly controlled hypertension at enrollment.
- Severe renal dysfunction with prior dialysis or kidney transplantation within 6 months prior to enrollment.
- Prior kidney biopsy-confirmed diagnosis of diabetic nephropathy.
Show all 17Show fewer
- History of severe or chronic infections within the 6 months before enrollment or current need for systemic antibiotic or antiviral therapy.
- Cardiovascular or cerebrovascular events requiring hospitalization within 6 months prior to enrollment.
- Severe or poorly controlled comorbidities that may affect protocol compliance or efficacy evaluation.
- Active Tuberculosis (TB) with documented evidence of infection.
- History of solid organ or bone marrow transplantation.
- Live vaccination, major surgery, or participated in other clinical trials with investigational drug use within 28 days prior to enrollment.
- HBsAg-positive, or HBcAb-positive with detectable HBV DNA above the normal range; HCV antibody-positive; HIV seropositive; Treponema pallidum antibody-positive.
- CD4+ T lymphocyte count <200 cells/μL
- Known hypersensitivity to any component of YK012.
- Pregnancy, breastfeeding, or positive pregnancy test at screening; or plans to become pregnant during the trial or within 12 months after study completion, or unwillingness to use physical contraceptive methods during the study and for 12 months thereafter.
- Other conditions deemed by the investigator to make the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Minghui Zhao, M.D., +86-010-83572388, mhzhao@bjmu.edu.cn
Minghui Zhao, M.D.
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YK012 in the Treatment of Primary Membranous Nephropathy
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YK012 in participants with primary membranous nephropathy (PMN).
Read the detailed description
This clinical trial consists of Phase Ia and Phase Ib. The goal of phase Ia is to evaluate the safety and tolerability of YK012 in participants with primary membranous nephropathy and to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE). The goal of phase Ib is to assess the preliminary efficacy of YK012 in participants with primary membranous nephropathy and to establish the recommended Phase II dose (RP2D).
- Conditions
- Primary Membranous Nephropathy
- Being tested
- YK012
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YK012Drug
Also called YK012 Infusion
YK012 is a bispecific antibody targeting CD19 on B cells and CD3 on T cells leading to T cell-mediated cytotoxicity of malignant B cells
| Study group | Role | What they receive |
|---|---|---|
| Ia: YK012 | Experimental | Participants with primary membranous nephropathy will receive ascending doses of YK012 infusion to evaluate the safety and tolerability of YK012 Receives: Drug: YK012 |
| Ib: YK012 | Experimental | Participants will receive 2 different doses of YK012 infusion to assess the preliminary efficacy of YK012 in participants with primary membranous nephropathy and to establish the recommended Phase II dose (RP2D). Receives: Drug: YK012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ia: Dose-limiting Toxicity(DLT)
Dose-limiting toxicities (DLTs) is defined as adverse events occurring within 28 days after the first dose and assessed by the investigator as related to the Investigational Medicinal Product (IMP).
Measured: up to 28 days after the first dose
Ia: Adverse Event (AE)
An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
Measured: From the first induction to the end of the trial at 53 weeks
Ia: Severe Adverse Event
An SAE refers to any untoward medical occurrence after the participant receives the IMP that results in one or more of the following: death, life-threatening event, permanent or serious disability or loss of function, hospitalization or prolongation of hospitalization, congenital abnormalities or birth defects.
Measured: From the first induction to the end of the trial at 53 weeks
Ib: Proportion of participants achieving overall response
Measured: From enrollment to the end of the trial at 76 weeks (if applicable)
Secondary outcomes (27)
Ia: Area Under the Curve (AUC) of a serum concentration versus time profile
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Area Under the Curve of a serum concentration to infinite time (AUC0-infinity)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Maximum concentration (Cmax) of YK012
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Time to reach Cmax (Tmax)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Elimination half life (t1/2)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Total Apparent Clearance (CL)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Apparent volume of distribution(Vd)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Minimum Concentration (Cmin) of YK012
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: The duration of peripheral blood B-cell depletion
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: The profile of peripheral blood NK cell changes
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: The profile of peripheral blood T-cell changes
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: The profile of cytokine changes
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: ADA (anti-drug antibody) and Nab (Neutralizing antibody) positivity rate
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
24-hour urine protein change
Measured: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
eGFR (Glomerular Filtration Rate) change
Measured: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Anti-PLA2R antibody titer change
Measured: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Ia: Proportion of participants achieving overall response
Measured: From enrollment to the end of the trial at 53 weeks
Proportion of participants achieving CR or PR
Measured: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Proportion of anti-PLA2R antibody-positive participants achieving immunological remission
Measured: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Time to achieve complete renal remission
Measured: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Time to achieve overall renal response
Measured: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Duration of complete renal response
Measured: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Duration of overall renal response
Measured: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Proportion of participants with treatment failure
Measured: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Proportion of participants with relapse
Measured: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Ib: Adverse Event (AE)
An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
Measured: From the first induction to the end of the trial at 53 or 77 (if applicable) weeks
Ib: Severe Adverse Event
An SAE refers to any untoward medical occurrence after the participant receives the IMP that results in one or more of the following: death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization, congenital abnormalities or birth defects.
Measured: From the first induction to the end of the trial at 53 or 77 (if applicable) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start8 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Excyte Biopharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minghui Zhao, M.D., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982729
- Sponsor's protocol ID
- YK012-3-CN
- Status last verified
- Nov 2025
- First submitted
- 6 May 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YK012 in the Treatment of Primary Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT06982729
- Acronym / sponsor ID
- YK012-3-CN
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Excyte Biopharma LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 May 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 goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YK012 in participants with primary membranous nephropathy (PMN).
Detailed description
This clinical trial consists of Phase Ia and Phase Ib. The goal of phase Ia is to evaluate the safety and tolerability of YK012 in participants with primary membranous nephropathy and to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE). The goal of phase Ib is to assess the preliminary efficacy of YK012 in participants with primary membranous nephropathy and to establish the recommended Phase II dose (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ia: YK012 | Experimental | Drug: YK012Participants with primary membranous nephropathy will receive ascending doses of YK012 infusion to evaluate the safety and tolerability of YK012 |
| Ib: YK012 | Experimental | Drug: YK012Participants will receive 2 different doses of YK012 infusion to assess the preliminary efficacy of YK012 in participants with primary membranous nephropathy and to establish the recommended Phase II dose (RP2D). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 80 years (inclusive), regardless of gender.
- Kidney biopsy-confirmed diagnosis of primary (idiopathic) membranous nephropathy within the past 10 years.
- Elevated 24-hour urine protein, meeting the pre-defined criteria.
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m² as calculated by the CKD-EPI equation.
- If currently taking an angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or sodium-glucose cotransporter-2 (SGLT-2) inhibitor, the dose must have been stable for at least 4 weeks prior to enrollment or since initiation of therapy.
Key exclusion criteria (17 listed)
- Diagnosis of secondary membranous nephropathy.
- Any prior receipt of protocol-specified pharmacological treatment for membranous nephropathy.
- History of malignancy within 5 years prior to enrollment.
- Poorly controlled hypertension at enrollment.
- Severe renal dysfunction with prior dialysis or kidney transplantation within 6 months prior to enrollment.
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 |
|---|---|---|
| YK012Also: YK012 InfusionYK012 is a bispecific antibody targeting CD19 on B cells and CD3 on T cells leading to T cell-mediated cytotoxicity of malignant B cells | Drug | Ia: YK012, Ib: YK012 |
Primary outcome
Ia: Dose-limiting Toxicity(DLT)
Time frame: up to 28 days after the first dose
Dose-limiting toxicities (DLTs) is defined as adverse events occurring within 28 days after the first dose and assessed by the investigator as related to the Investigational Medicinal Product (IMP).
Ia: Adverse Event (AE)
Time frame: From the first induction to the end of the trial at 53 weeks
An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
Ia: Severe Adverse Event
Time frame: From the first induction to the end of the trial at 53 weeks
An SAE refers to any untoward medical occurrence after the participant receives the IMP that results in one or more of the following: death, life-threatening event, permanent or serious disability or loss of function, hospitalization or prolongation of hospitalization, congenital abnormalities or birth defects.
Ib: Proportion of participants achieving overall response
Time frame: From enrollment to the end of the trial at 76 weeks (if applicable)
27 secondary outcomes
Ia: Area Under the Curve (AUC) of a serum concentration versus time profile
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Area Under the Curve of a serum concentration to infinite time (AUC0-infinity)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Maximum concentration (Cmax) of YK012
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Time to reach Cmax (Tmax)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Elimination half life (t1/2)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Total Apparent Clearance (CL)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Apparent volume of distribution(Vd)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: Minimum Concentration (Cmin) of YK012
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: The duration of peripheral blood B-cell depletion
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: The profile of peripheral blood NK cell changes
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: The profile of peripheral blood T-cell changes
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: The profile of cytokine changes
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
Ia: ADA (anti-drug antibody) and Nab (Neutralizing antibody) positivity rate
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 weeks
24-hour urine protein change
Time frame: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
eGFR (Glomerular Filtration Rate) change
Time frame: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Anti-PLA2R antibody titer change
Time frame: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Ia: Proportion of participants achieving overall response
Time frame: From enrollment to the end of the trial at 53 weeks
Proportion of participants achieving CR or PR
Time frame: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Proportion of anti-PLA2R antibody-positive participants achieving immunological remission
Time frame: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Time to achieve complete renal remission
Time frame: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Time to achieve overall renal response
Time frame: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Duration of complete renal response
Time frame: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Duration of overall renal response
Time frame: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Proportion of participants with treatment failure
Time frame: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Proportion of participants with relapse
Time frame: From enrollment to the end of the trial at 53 or 77 (if applicable) weeks
Ib: Adverse Event (AE)
Time frame: From the first induction to the end of the trial at 53 or 77 (if applicable) weeks
Ib: Severe Adverse Event
Time frame: From the first induction to the end of the trial at 53 or 77 (if applicable) weeks
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 17 Nov 2025.
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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.
Minghui Zhao, M.D. principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YK012 in people with Primary Membranous Nephropathy, run by Excyte Biopharma Ltd 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 7 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 17 Nov 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Minghui Zhao, M.D. (+86-010-83572388, mhzhao@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ia: Dose-limiting Toxicity(DLT) (time frame: up to 28 days after the first dose). The study lists 4 primary outcomes in all. 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 17 Nov 2025.