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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Ia: Dose-Limiting Toxicity (DLT) | up to 28 days after the first dose | |
| Adverse Event (AE) | From the first induction to the end of the trial at 53 weeks | |
| Severe Adverse Event | From the first induction to the end of the trial at 53 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC0-t) | 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-∞) | From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minghui Zhao, M.D. | Contact | +86-010-83572388 | mhzhao@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Minghui Zhao | Peking University First Hospital | Principal Investigator |
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| Maximum plasma concentration (Cmax) | 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) | From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks |
| Half-life (t1/2) | From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks |
| Apparent clearance (CL) | From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks |
| apparent volume of distribution (Vd) | From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks |
| Minimum plasma concentration (Cmin) | 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 | 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 | 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) | From 1 hour before the first infusion of YK012 to the end of trial at 53 or 77 weeks |
| The profile of cytokine changes | 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) | 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 | 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 | 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 | From screening to the end of the trial at 53 or 77 weeks |
| Proportion of participants achieving overall renal remission (ORR) | From screening to the end of the trial at 53 or 77 weeks |
| Proportion of participants achieving Complete Response (CR) and Partial Response (PR) | From screening to the end of the trial at 53 or 77 weeks |
| Proportion of participants achieving immunological remission | From screening to the end of the trial at 53 or 77 weeks |
| Time to achieve CR | From screening to the end of the trial at 53 or 77 weeks |
| Time to achieve ORR | From screening to the end of the trial at 53 or 77 weeks |
| Duration of CR | From screening to the end of the trial at 53 or 77 weeks |
| Duration of ORR | From screening to the end of the trial at 53 or 77 weeks |
| Proportion of participants with treatment failure | From screening to the end of the trial at 53 or 77 weeks |
| Proportion of participants who relapsed | From screening to the end of the trial at 53 or 77 weeks |