Primary Membranous NephropathyPhase 1NCT07234474
A Phase I Study of YK012 in Primary Membranous Nephropathy
A Phase 1 study testing YK012 in people with Primary Membranous Nephropathy, run by Excyte Biopharma Ltd.
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
- 66 participants
- Where
- No sites listed yet
- Study dates
- Sep 2027to Jan 2029
- 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
- Age 18-80 (inclusive), both gender.
- Diagnosed with primary (idiopathic) membranous nephropathy by renal biopsy within 10 years.
- Participants who meet the criteria of very high-risk primary (idiopathic) membranous nephropathy based on 2021 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Management of Glomerular Diseases and who have failed available therapies for the treatment of pMN.
- eGFR estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula is ≥45 mL/min/1.73 m².
- If taking angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), or Sodium-Glucose Co-Transporter 2 (SGLT-2) inhibitor, the medication dosage must have been stable (≤50% change in dose) for at least 4 weeks prior to screening and continue being stable prior to the initiation of the investigational product.
- Laboratory tests within 7 days prior to enrollment meet the pre-defined criteria.
- Be able to understand and voluntarily participate in this clinical trial with written signed informed consent and available for scheduled visits, treatments, examinations, and other study procedures.
Who cannot join
- Diagnosed with secondary membranous nephropathy.
- Any prior receipt of protocol-specified pharmacological treatment for membranous nephropathy.
- History of malignant tumor within 5 years prior to screening.
- Poorly controlled hypertension.
- Participants with severe renal insufficiency who have received or require dialysis or kidney transplantation within 6 months prior to the initiation of the investigational product.
- History of diabetic nephropathy confirmed by renal biopsy.
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- History of severe or chronic infections within 6 months prior to screening or currently infection requiring systemic antibiotic or antiviral therapy.
- History of cardiovascular event leading to hospitalization within 6 months prior to screening.
- Other severe or poorly controlled diseases that may affect the protocol compliance or efficacy assessments.
- Have active tuberculosis with clear evidence of infection.
- History of substantial organ or bone marrow transplantation.
- Received live vaccination, underwent major surgery, or participated in other clinical trials and applied any other study drugs within 28 days prior to the initiation of the investigational product.
- Hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive with hepatitis B virus (HBV) DNA quantification ≥ 1×103 copies/L or ≥ 50 IU/L (HBcAb positive participants require regular HBV DNA testing); Hepatitis C virus (HCV) antibody positive; Human immunodeficiency virus (HIV) seropositive; Syphilis helical antibody positive.
- Peripheral blood CD4+ T-lymphocyte count < 200 cells/μL.
- The peripheral blood B-cell count is below the lower limit of normal.
- Known hypersensitivity to any of the ingredients of YK012.
- Female participants who are pregnant or breastfeeding, or women of childbearing potential (WOCBP) who have a positive pregnancy test result at screening; or those who plan to have children during the trial period and for 12 months after the end of the trial, and those who are unwilling to use one or more physical contraceptive methods during the trial period and for 12 months after the end of the trial.
- Other conditions that the investigator considers inappropriate for participation in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Study of YK012, a Humanized CD19 × CD3 Bispecific Antibody, in Participants With Very High-Risk, Refractory 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).
- 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
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, and to determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE) Receives: Drug: YK012 |
| Ib: YK012 | Experimental | Participants will receive 2 different doses of YK012 infusion to evaluate the safety and tolerability 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)
Measured: up to 28 days after the first dose
Adverse Event (AE)
Measured: From the first induction to the end of the trial at 53 weeks
Severe Adverse Event
Measured: From the first induction to the end of the trial at 53 weeks
Secondary outcomes (25)
Area under the concentration-time curve (AUC0-t)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Area under the concentration-time curve from time 0 to ∞ (AUC0-∞)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Maximum plasma concentration (Cmax)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Time to reach maximum concentration (Tmax)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Half-life (t1/2)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Apparent clearance (CL)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
apparent volume of distribution (Vd)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Minimum plasma concentration (Cmin)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Time to onset and duration of peripheral blood B-cell and B-cell subset depletion
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Changes in peripheral blood Natural Killer (NK) cells
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Changes in peripheral blood T cells and T cell subsets (CD4+ T cells, CD8+ T cells)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
The profile of cytokine changes
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Positive rates of blood anti-drug antibody (ADA) and neutralizing antibody (Nab)
Measured: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Changes from baseline in 24-hour urine protein during the trial period
Measured: From screening to the end of the trial at 53 or 77 weeks
Changes from baseline in estimated glomerular filtration rate (eGFR) during the trial period
Measured: From screening to the end of the trial at 53 or 77 weeks
Changes from baseline in anti-phospholipase A2 receptor (PLA2R) antibody titer during the trial period
Measured: From screening to the end of the trial at 53 or 77 weeks
Proportion of participants achieving overall renal remission (ORR)
Measured: From screening to the end of the trial at 53 or 77 weeks
Proportion of participants achieving Complete Response (CR) and Partial Response (PR)
Measured: From screening to the end of the trial at 53 or 77 weeks
Proportion of participants achieving immunological remission
Measured: From screening to the end of the trial at 53 or 77 weeks
Time to achieve CR
Measured: From screening to the end of the trial at 53 or 77 weeks
Time to achieve ORR
Measured: From screening to the end of the trial at 53 or 77 weeks
Duration of CR
Measured: From screening to the end of the trial at 53 or 77 weeks
Duration of ORR
Measured: From screening to the end of the trial at 53 or 77 weeks
Proportion of participants with treatment failure
Measured: From screening to the end of the trial at 53 or 77 weeks
Proportion of participants who relapsed
Measured: From screening to the end of the trial at 53 or 77 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study startSep 2027 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionJan 2029 (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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Excyte Biopharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minghui Zhao, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234474
- Sponsor's protocol ID
- YK012-3-FDA
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of YK012, a Humanized CD19 × CD3 Bispecific Antibody, in Participants With Very High-Risk, Refractory Primary Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT07234474
- Acronym / sponsor ID
- YK012-3-FDA
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Excyte Biopharma LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2027 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 18 Nov 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).
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, and to determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE) |
| Ib: YK012 | Experimental | Drug: YK012Participants will receive 2 different doses of YK012 infusion to evaluate the safety and tolerability 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)
- Age 18-80 (inclusive), both gender.
- Diagnosed with primary (idiopathic) membranous nephropathy by renal biopsy within 10 years.
- Participants who meet the criteria of very high-risk primary (idiopathic) membranous nephropathy based on 2021 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Management of Glomerular Diseases and who have failed available therapies for the treatment of pMN.
- eGFR estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula is ≥45 mL/min/1.73 m².
- If taking angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), or Sodium-Glucose Co-Transporter 2 (SGLT-2) inhibitor, the medication dosage must have been stable (≤50% change in dose) for at least 4 weeks prior to screening and continue being stable prior to the initiation of the investigational product.
Key exclusion criteria (18 listed)
- Diagnosed with secondary membranous nephropathy.
- Any prior receipt of protocol-specified pharmacological treatment for membranous nephropathy.
- History of malignant tumor within 5 years prior to screening.
- Poorly controlled hypertension.
- Participants with severe renal insufficiency who have received or require dialysis or kidney transplantation within 6 months prior to the initiation of the investigational product.
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 |
|---|---|---|
| YK012YK012 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
Adverse Event (AE)
Time frame: From the first induction to the end of the trial at 53 weeks
Severe Adverse Event
Time frame: From the first induction to the end of the trial at 53 weeks
25 secondary outcomes
Area under the concentration-time curve (AUC0-t)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Area under the concentration-time curve from time 0 to ∞ (AUC0-∞)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Maximum plasma concentration (Cmax)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Time to reach maximum concentration (Tmax)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Half-life (t1/2)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Apparent clearance (CL)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
apparent volume of distribution (Vd)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Minimum plasma concentration (Cmin)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Time to onset and duration of peripheral blood B-cell and B-cell subset depletion
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Changes in peripheral blood Natural Killer (NK) cells
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Changes in peripheral blood T cells and T cell subsets (CD4+ T cells, CD8+ T cells)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
The profile of cytokine changes
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Positive rates of blood anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time frame: From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks
Changes from baseline in 24-hour urine protein during the trial period
Time frame: From screening to the end of the trial at 53 or 77 weeks
Changes from baseline in estimated glomerular filtration rate (eGFR) during the trial period
Time frame: From screening to the end of the trial at 53 or 77 weeks
Changes from baseline in anti-phospholipase A2 receptor (PLA2R) antibody titer during the trial period
Time frame: From screening to the end of the trial at 53 or 77 weeks
Proportion of participants achieving overall renal remission (ORR)
Time frame: From screening to the end of the trial at 53 or 77 weeks
Proportion of participants achieving Complete Response (CR) and Partial Response (PR)
Time frame: From screening to the end of the trial at 53 or 77 weeks
Proportion of participants achieving immunological remission
Time frame: From screening to the end of the trial at 53 or 77 weeks
Time to achieve CR
Time frame: From screening to the end of the trial at 53 or 77 weeks
Time to achieve ORR
Time frame: From screening to the end of the trial at 53 or 77 weeks
Duration of CR
Time frame: From screening to the end of the trial at 53 or 77 weeks
Duration of ORR
Time frame: From screening to the end of the trial at 53 or 77 weeks
Proportion of participants with treatment failure
Time frame: From screening to the end of the trial at 53 or 77 weeks
Proportion of participants who relapsed
Time frame: From screening to the end of the trial at 53 or 77 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 30 Sep 2026.
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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 principal investigator
Peking University First Hospital
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.
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 18 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 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 30 Sep 2026.