A Study to Learn More About the Effects and Safety of JMT601 in Adults With Primary Membranous Ne… (NCT07029139) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Learn More About the Effects and Safety of JMT601 in Adults With Primary Membranous Nephropathy
156 participantsStarted 2025-06-30
Plain-language summary
This study is a multicenter, randomized, controlled, open-label, Phase Ⅱ clinical study to evaluate the efficacy, safety, Pharmacokinetics characteristics, Pharmacodynamics effects, and immunogenicity of JMT601 in participants with primary membranous nephropathy.
The study has two parts. Part one is dose escalation part, and Part two is dose expansion part.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. The age range is between 18 and 80 years old, regardless of gender.
✓. Diagnosed with primary membranous nephropathy by renal biopsy during the screening/induction period or within 24 months before screening. Pathological reports must be reviewed by the investigator prior to study drug administration.
✓. The glomerular filtration rate (eGFR) estimated by CKD-EPI formula is ≥ 40ml/min/1.73m\^2, or the endogenous creatinine clearance rate (CrCl) based on 24-hour urine examination is ≥ 40ml/min.
✓. Participants taking angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists must maintain a stable dose for at least 4 weeks before screening;
✓. Participants with systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening.
✓. During the screening period and the baseline visit, the 24-hour urine protein is \> 3.5g.
✓. Have never received immunosuppressive therapy for PMN (cyclophosphamide, calcineurin inhibitors, such as cyclosporine and tacrolimus) and B cell exhaustion therapy (such as rituximab); or relapsed after receiving the above treatment to achieve complete remission or partial remission (comprehensively judged and recorded by the researcher), and have not received the above treatment after recurrence (excluding those who are ineffective or resistant to B cell depletion drugs).
✓. Have fully understood this study and voluntarily signed the informed consent form.
✕. Diagnostic renal biopsy shows evidence of glomerular crescent formation, which suggests the diagnosis of other renal diseases or renal biopsy evidence of interstitial fibrosis/tubular atrophy in cortical area \> 50%.
✕. Uncontrolled blood pressure as judged by the investigator within the 3 months prior to screening.
✕. Individuals with evidence of a ≥50% decrease in urine protein within the first 6 months before screening.
✕. Currently undergoing or planning to undergo renal replacement therapy during the study period.
✕. Type 1 diabetes or type 2 diabetes with diabetic nephropathy (confirmed by renal biopsy report) or without biopsy-confirmed diabetic nephropathy but with a diabetes duration ≥5 years.
✕. Presence of severe, progressive, or uncontrolled comorbidities.
✕. Individuals who have had or currently have malignant tumors.