A Study to Learn More About the Effects and Safety of JMT601 in Adults With Primary Membranous Nephropathy

NCT07029139 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: JMT601-003
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Primary Membranous Nephropathy

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events in Part 1

  Up to 24 weeks

• Overall Remission Rate at week 52 in Part 2

  Participants with overall remission are those achieving either complete remission or partial remission

  week 52

Secondary Outcomes (20)

• Blood drug concentration of JMT-601 in Part 1

  week 24

• Immunological remission in the anti-PLA2R antibody positive population in Part 1

  week 12, 24

• Changes in anti-PLA2R antibody titers from baseline in anti-PLA2R antibody positive population in Part 1

  week 24

• Overall Remission Rate in Part 1

  weeks 12, 24

• Complete Remission Rate in Part 1

  weeks 12, 24

Study Arms (4)

JMT601 (Part 1)

EXPERIMENTAL

JMT601

Drug: JMT601 Injection

Rituximab (Part 1)

ACTIVE COMPARATOR

Rituximab

Drug: JMT601 Injection; Drug: Cyclosporin Capsules

JMT601 (Part 2)

EXPERIMENTAL

JMT601

Drug: Rituximab; Drug: Cyclosporin Capsules

Cyclosporin Capsules (part 2)

ACTIVE COMPARATOR

Cyclosporin Capsules

Drug: JMT601 Injection; Drug: Rituximab

Interventions

JMT601 Injection DRUG

In accordance with the protocol

Cyclosporin Capsules (part 2); JMT601 (Part 1); Rituximab (Part 1)

Rituximab DRUG

In accordance with the protocol

Cyclosporin Capsules (part 2); JMT601 (Part 2)

Cyclosporin Capsules DRUG

In accordance with the protocol

JMT601 (Part 2); Rituximab (Part 1)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Secondary membranous nephropathy.
• 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.
• Participants with autoimmune diseases requiring systemic immunosuppression therapy, or those judged by researchers to have autoimmune diseases that interfere with the clinical evaluation of primary membranous nephropathy or are not suitable for clinical trials.
• A history of previous or current hemolytic anemia, Evans syndrome, arteritis.
• Participants with suspected active or latent tuberculosis patients based on medical history or tuberculosis screening.
• Severe active bacterial, viral, fungal, mycobacterial, parasitic, or other infections requiring systemic antibiotics or antiviral treatment within 1 month before screening.
• Have received prescribed treatment for membranous nephropathy before screening.
• Participants using of complementary therapies that may interfere with the investigator's assessment of participant efficacy and safety within 4 weeks prior to randomization.
• Live vaccines or major surgery within 28 days before the investigational drug administration or undergoing major surgery.

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

MeSH Terms

Interventions

Rituximab; Cyclosporine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multi-center, randomized, controlled, open-label Phase II clinical study.

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 19, 2025

Record last verified: 2025-06