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A Phase I Study of YK012 in Primary Membranous Nephropathy

ConditionPrimary Membranous Nephropathy
Trial statusNot yet recruiting
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

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.

Disqualifiers

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.

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

66 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)

Time frame
up to 28 days after the first dose
2

Adverse Event (AE)

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

Severe Adverse Event

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Excyte Biopharma Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: