Health TrialsbyHealthPanel

Study of YK012 in Primary Membranous Nephropathy

ConditionPrimary Membranous Nephropathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorExcyte Biopharma Ltd

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • YK012

    Drug

    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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Ia: YK012Experimental treatment 1 intervention
Group B: Ib: YK012Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
up to 28 days after the first dose
2

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.

Time frame
From the first induction to the end of the trial at 53 weeks
3

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.

Time frame
From the first induction to the end of the trial at 53 weeks
4

Ib: Proportion of participants achieving overall response

Time frame
From enrollment to the end of the trial at 76 weeks (if applicable)

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Excyte Biopharma Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now