Recruiting NCT06982729
Study of YK012 in Primary Membranous Nephropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: YK012.
- Who it may be relevant to
- Registry conditions: Primary Membranous Nephropathy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- 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
Primary outcome measures
- Ia: Dose-limiting Toxicity(DLT) [Time frame: 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]
- Ia: Severe Adverse Event [Time frame: 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)]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT06982729 · YK012-3-CN