Study of YK012 in Primary Membranous Nephropathy

November 14, 2025 updated by: Excyte Biopharma Ltd

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Principal Investigator:
          • Minghui Zhao, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ia: YK012
Participants with primary membranous nephropathy will receive ascending doses of YK012 infusion to evaluate the safety and tolerability of YK012
Drug: YK012
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
Other Names:
  • YK012 Infusion
Experimental: Ib: YK012
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).
Drug: YK012
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
Other Names:
  • YK012 Infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
up to 28 days after the first dose
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.
From the first induction to the end of the trial at 53 weeks
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.
From the first induction to the end of the trial at 53 weeks
Ib: Proportion of participants achieving overall response
Time Frame: From enrollment to the end of the trial at 76 weeks (if applicable)
From enrollment to the end of the trial at 76 weeks (if applicable)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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.
From the first induction to the end of the trial at 53 or 77 (if applicable) weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Excyte Biopharma Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Minghui Zhao, M.D., Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YK012-3-CN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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