Primary Membranous NephropathyPhase 2NCT07029139
A Study to Learn More About the Effects and Safety of JMT601 in Adults With Primary Membranous Nephropathy
A Phase 2 study testing JMT601 Injection, Rituximab and Cyclosporin Capsules in people with Primary Membranous Nephropathy, run by Shanghai JMT-Bio Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- JMT601 Injection, Rituximab and Cyclosporin Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 1 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Participants who have participated in clinical trials of other drugs with a screening time less than 30 days from the last administration or the five half-lives of the original drug (whichever is longer), or those who plan to participate in clinical trials of another drug during the study period.
- Participants who have received targeted CD47 or signal regulatory protein α (SIRPα) therapy.
- A history of alcoholism or drug abuse within 12 months.
- Virology test results at screening meet the criteria:
- HBsAg positivity; If HBsAg is negative and HBcAb is positive, HBV DNA should be exceeding the upper limit of the local laboratory reference range; Positive hepatitis C virus (HCV) antibody with detectable HCV RNA; Positive serology for human immunodeficiency virus (HIV).
- Any of the following abnormal laboratory test results during screening: hemoglobin<80g/L, platelet count<100× 10^9/L , absolute neutrophil count<1.5× 10^9/L , AST or ALT values>2× upper limit of normal (ULN), CD4+ T lymphocyte count < 300 cells/μL, QTcF>450 ms for males and >460 ms for females.
- Participants who have previously shown resistance to CD20 inhibitors or cyclosporine.
- Known history of severe hypersensitivity reactions to humanized monoclonal antibodies or documented allergy to any component of rituximab (dose-escalation part only), JMT601 injection, or cyclosporine (dose-expansion part only).
- Pregnant or lactating women; Women of childbearing potential not undergoing sterilization who are unwilling to use adequate contraception during treatment and for at least 6 months after the last dose of the investigational drug.
- Men not undergoing sterilization who are unwilling to use barrier contraception during the study and for at least 6 months after the last dose of the investigational drug, and who refuse to ensure their partners use additional contraceptive methods (e.g., oral contraceptives, intrauterine devices, barrier methods, or spermicides).
- Other conditions that the investigator deems render the subject unsuitable for study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Controlled, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JMT601 Injection in Participants With Primary Membranous Nephropathy
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
- Being tested
- JMT601 Injection, Rituximab, Cyclosporin Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT601 InjectionDrug
In accordance with the protocol
RituximabDrug
In accordance with the protocol
Cyclosporin CapsulesDrug
In accordance with the protocol
| Study group | Role | What they receive |
|---|---|---|
| JMT601 (Part 1) | Experimental | JMT601 Receives: Drug: JMT601 Injection |
| Rituximab (Part 1) | Active comparator | Rituximab Receives: Drug: JMT601 Injection; Drug: Cyclosporin Capsules |
| JMT601 (Part 2) | Experimental | JMT601 Receives: Drug: Rituximab; Drug: Cyclosporin Capsules |
| Cyclosporin Capsules (part 2) | Active comparator | Cyclosporin Capsules Receives: Drug: JMT601 Injection; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events in Part 1
Measured: 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
Measured: week 52
Secondary outcomes (20)
Blood drug concentration of JMT-601 in Part 1
Measured: week 24
Immunological remission in the anti-PLA2R antibody positive population in Part 1
Proportion of anti-PLA2R antibody-positive participants achieving immunological remission
Measured: week 12, 24
Changes in anti-PLA2R antibody titers from baseline in anti-PLA2R antibody positive population in Part 1
Measured: week 24
Overall Remission Rate in Part 1
Measured: weeks 12, 24
Complete Remission Rate in Part 1
A complete remission is defined as UPCR (based on 24-hour urine collection) ≤ 0.3, and a stable eGFR (remaining unchanged or decreasing by ≤ 15% compared with the baseline)
Measured: weeks 12, 24
ADA (anti-drug antibody) positivity rate of JMT-601 in Part 1
Measured: week 24
Nab (Neutralizing antibody) positivity rate of JMT-601 in Part 1
Measured: week 24
Complete remission rate in Part 2
Complete remission is defined as UPCR (based on 24-hour urine collection) ≤ 0.3, and a stable eGFR (remaining unchanged or decreasing by ≤ 15% compared with the baseline).
Measured: week 24, 52, 76, 104
Overall remission rate in Part 2
Participants with overall remission are those achieving either complete remission or partial remission. Partial remission is defined as a reduction of proteinuria to 0.3-3.5 g/24 h and 50% lower than baseline with stable renal function.
Measured: week 24, 52, 76, 104
Relapse rate in Part 2
A relapse is defined as reappearance of UPCR (based on 24-hour urine collection) > 3.5 after complete or partial remission
Measured: week 52, 76, 104
Time to first complete remission in Part 2
Measured: week 104
Time to first overall remission in Part 2
Measured: week 104
Time to first relapse in Part 2
Measured: week 104
Change of urine protein from baseline in Part 2
Measured: week 12, 24, 52, 76, 104
Change of estimated Glomerular Filtration Rate (eGFR) from baseline in Part 2
Measured: week 12, 24, 52, 76, 104
Immunological response in the anti-PLA2R antibody positive population in Part 2
Measured: week 12, 24, 52, 76, 104
Blood drug concentration of JMT-601 in Part 2
Measured: week 104
ADA (anti-drug antibody) positivity rate of JMT-601 in Part 2
Measured: week 104
Nab (Neutralizing antibody) positivity rate of JMT-601 in Part 2
Measured: week 104
Adverse Events (AEs) in Part 2
Measured: week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-center, randomized, controlled, open-label Phase II clinical study.
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029139
- Sponsor's protocol ID
- JMT601-003
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JMT601 Injection in Participants With Primary Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT07029139
- Acronym / sponsor ID
- JMT601-003
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a multi-center, randomized, controlled, open-label Phase II clinical study.
| Arm | Type | Receives |
|---|---|---|
| JMT601 (Part 1) | Experimental | Drug: JMT601 InjectionJMT601 |
| Rituximab (Part 1) | Active comparator | Drug: JMT601 Injection, Drug: Cyclosporin CapsulesRituximab |
| JMT601 (Part 2) | Experimental | Drug: Rituximab, Drug: Cyclosporin CapsulesJMT601 |
| Cyclosporin Capsules (part 2) | Active comparator | Drug: JMT601 Injection, Drug: RituximabCyclosporin Capsules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMT601 InjectionIn accordance with the protocol | Drug | Cyclosporin Capsules (part 2), JMT601 (Part 1), Rituximab (Part 1) |
| RituximabIn accordance with the protocol | Drug | Cyclosporin Capsules (part 2), JMT601 (Part 2) |
| Cyclosporin CapsulesIn accordance with the protocol | Drug | JMT601 (Part 2), Rituximab (Part 1) |
Primary outcome
Incidence of adverse events in Part 1
Time frame: Up to 24 weeks
Overall Remission Rate at week 52 in Part 2
Time frame: week 52
Participants with overall remission are those achieving either complete remission or partial remission
20 secondary outcomes
Blood drug concentration of JMT-601 in Part 1
Time frame: week 24
Immunological remission in the anti-PLA2R antibody positive population in Part 1
Time frame: week 12, 24
Changes in anti-PLA2R antibody titers from baseline in anti-PLA2R antibody positive population in Part 1
Time frame: week 24
Overall Remission Rate in Part 1
Time frame: weeks 12, 24
Complete Remission Rate in Part 1
Time frame: weeks 12, 24
ADA (anti-drug antibody) positivity rate of JMT-601 in Part 1
Time frame: week 24
Nab (Neutralizing antibody) positivity rate of JMT-601 in Part 1
Time frame: week 24
Complete remission rate in Part 2
Time frame: week 24, 52, 76, 104
Overall remission rate in Part 2
Time frame: week 24, 52, 76, 104
Relapse rate in Part 2
Time frame: week 52, 76, 104
Time to first complete remission in Part 2
Time frame: week 104
Time to first overall remission in Part 2
Time frame: week 104
Time to first relapse in Part 2
Time frame: week 104
Change of urine protein from baseline in Part 2
Time frame: week 12, 24, 52, 76, 104
Change of estimated Glomerular Filtration Rate (eGFR) from baseline in Part 2
Time frame: week 12, 24, 52, 76, 104
Immunological response in the anti-PLA2R antibody positive population in Part 2
Time frame: week 12, 24, 52, 76, 104
Blood drug concentration of JMT-601 in Part 2
Time frame: week 104
ADA (anti-drug antibody) positivity rate of JMT-601 in Part 2
Time frame: week 104
Nab (Neutralizing antibody) positivity rate of JMT-601 in Part 2
Time frame: week 104
Adverse Events (AEs) in Part 2
Time frame: week 104
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JMT601 Injection, Rituximab and Cyclosporin Capsules in people with Primary Membranous Nephropathy, run by Shanghai JMT-Bio Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events in Part 1 (time frame: Up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.