Lupus NephritisPhase 1/2NCT07044115
Evaluation of the Tolerance, Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of MIL62 Injection for Treating Lupus Nephritis
A Phase 1/2 study testing Recombinant Humanized Monoclonal Antibody MIL62 Injection in people with Lupus Nephritis, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
Trial summary
This study is composed of two stages: Part A is a randomized, double-blind, placebo-controlled dose-escalation study (i.e., Phase 1b study). The first part has a total of 3 dose groups, with 10 subjects enrolled in each dose group. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Recombinant Humanized Monoclonal Antibody MIL62 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2021to Aug 2025
- Phase
- Phase 1/2
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and <75 years, gender not restricted;
- Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria;
- Urinary protein/creatinine ratio (UPCR) > 1.0 (24-hour urine);
- If the patient is taking drugs that may affect kidney function (e.g., ACE inhibitors, cholesterol-lowering drugs), the dosage must remain stable for at least 4 weeks prior to enrollment and throughout the study;
- No need to receive vaccination during the study or need vaccination only after at least 16 weeks following the last dose of study drug;
- Signed written informed consent.
Who cannot join
- Screening reveals other severe kidney diseases or conditions, including: ① Need for dialysis or transplant therapy; ② Kidney biopsy within the last 6 months shows more than 50% glomerulosclerosis;
- Screening reveals the following diseases or conditions: ① Other autoimmune diseases besides SLE; ② Clinically significant bleeding risks, or conditions requiring plasma exchange, blood transfusion, or platelet transfusion;
- Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA levels outside normal range; positive for HCV antibody and HCV RNA; positive for HIV serum reaction; positive for syphilis test;
- Pregnant and breastfeeding women; for women of childbearing potential who have not undergone sterilization: unwilling to use appropriate contraception methods (e.g., oral contraceptives, intrauterine devices, or barrier methods with spermicide) during the treatment period and for at least 18 months after the last dose of study drug;
- For men who have not undergone sterilization: unwilling to use barrier contraception during the study and for at least 18 months after the last dose of study drug, and unwilling to have their spouse use other contraception methods;
- The investigator considers other situations not suitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b/2 Clinical Study Evaluating the Tolerance, Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in Subjects With Lupus Nephritis
This study is composed of two stages: Part A is a randomized, double-blind, placebo-controlled dose-escalation study (i.e., Phase 1b study). The first part has a total of 3 dose groups, with 10 subjects enrolled in each dose group. Subjects are randomly assigned to receive MIL62 combined with standard of care or placebo combined with standard of care at a 4:1 ratio. Based on the tolerability, safety, pharmacodynamics, pharmacokinetics, and preliminary efficacy of the 3 dose groups, the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and dosing frequency will be determined.
Part B is open-label, enrolling 10 subjects who will receive the recommended dose of MIL62 combined with standard of care.
- Conditions
- Lupus Nephritis
- Being tested
- Recombinant Humanized Monoclonal Antibody MIL62 Injection, placebo
- Keywords
- Lupus Nephritis, CD20 monoclonal antibody, MIL62
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Humanized Monoclonal Antibody MIL62 InjectionDrug
Phase 1b:
Intravenous infusion. Dose group 1 (500mg), dose group 2 (1000mg); administered on Day 1 of Weeks 1, 3, 25, 27, 53, 55, and 77. Dose group 3 (500mg), administered on Days 1, 2, 3, 4, 25, 26, 27, 28, 53, 54, 55, 56, 77, and 78 of each respective week.
Phase 2:
Use the dose and frequency determined in Phase 1b.
placeboDrug
Phase 1b:
Intravenous infusion. Dose group 1 (500mg), dose group 2 (1000mg); administered on Day 1 of Weeks 1, 3, 25, 27, 53, 55, and 77. Dose group 3 (500mg), administered on Days 1, 2, 3, 4, 25, 26, 27, 28, 53, 54, 55, 56, 77, and 78 of each respective week.
Phase 2:
Use the dose and frequency determined in Phase 1b.
| Study group | Role | What they receive |
|---|---|---|
| MIL62 | Experimental | Not described Receives: Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieving complete renal remission (CRR) at 76 weeks
Percentage of Participants with UPCR < 0.3 and estimated glomerular filtration rate (eGFR) decline ≤ 15% from baseline
Measured: week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start26 Nov 2021
- Primary completion16 Jan 2025
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Beijing Mabworks Biotech Co., Ltd.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044115
- Sponsor's protocol ID
- MIL62-CT203
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Clinical Study Evaluating the Tolerance, Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in Subjects With Lupus Nephritis
- ClinicalTrials.gov ID
- NCT07044115
- Acronym / sponsor ID
- MIL62-CT203
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis, CD20 monoclonal antibody, MIL62
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 29 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 composed of two stages: Part A is a randomized, double-blind, placebo-controlled dose-escalation study (i.e., Phase 1b study). The first part has a total of 3 dose groups, with 10 subjects enrolled in each dose group. Subjects are randomly assigned to receive MIL62 combined with standard of care or placebo combined with standard of care at a 4:1 ratio. Based on the tolerability, safety, pharmacodynamics, pharmacokinetics, and preliminary efficacy of the 3 dose groups, the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and dosing frequency will be determined.
Part B is open-label, enrolling 10 subjects who will receive the recommended dose of MIL62 combined with standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIL62 | Experimental | Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years and <75 years, gender not restricted;
- Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria;
- Urinary protein/creatinine ratio (UPCR) > 1.0 (24-hour urine);
- If the patient is taking drugs that may affect kidney function (e.g., ACE inhibitors, cholesterol-lowering drugs), the dosage must remain stable for at least 4 weeks prior to enrollment and throughout the study;
- No need to receive vaccination during the study or need vaccination only after at least 16 weeks following the last dose of study drug;
Key exclusion criteria (6 listed)
- Screening reveals other severe kidney diseases or conditions, including: ① Need for dialysis or transplant therapy; ② Kidney biopsy within the last 6 months shows more than 50% glomerulosclerosis;
- Screening reveals the following diseases or conditions: ① Other autoimmune diseases besides SLE; ② Clinically significant bleeding risks, or conditions requiring plasma exchange, blood transfusion, or platelet transfusion;
- Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA levels outside normal range; positive for HCV antibody and HCV RNA; positive for HIV serum reaction; positive for syphilis test;
- Pregnant and breastfeeding women; for women of childbearing potential who have not undergone sterilization: unwilling to use appropriate contraception methods (e.g., oral contraceptives, intrauterine devices, or barrier methods with spermicide) during the treatment period and for at least 18 months after the last dose of study drug;
- For men who have not undergone sterilization: unwilling to use barrier contraception during the study and for at least 18 months after the last dose of study drug, and unwilling to have their spouse use other contraception methods;
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 |
|---|---|---|
| Recombinant Humanized Monoclonal Antibody MIL62 InjectionPhase 1b: Intravenous infusion. Dose group 1 (500mg), dose group 2 (1000mg); administered on Day 1 of Weeks 1, 3, 25, 27, 53, 55, and 77. Dose group 3 (500mg), administered on Days 1, 2, 3, 4, 25, 26, 27, 28, 53, 54, 55, 56, 77, and 78 of each respective week. Phase 2: Use the dose and frequency determined in Phase 1b. | Drug | MIL62 |
| placeboPhase 1b: Intravenous infusion. Dose group 1 (500mg), dose group 2 (1000mg); administered on Day 1 of Weeks 1, 3, 25, 27, 53, 55, and 77. Dose group 3 (500mg), administered on Days 1, 2, 3, 4, 25, 26, 27, 28, 53, 54, 55, 56, 77, and 78 of each respective week. Phase 2: Use the dose and frequency determined in Phase 1b. | Drug | placebo |
Primary outcome
Percentage of subjects achieving complete renal remission (CRR) at 76 weeks
Time frame: week 76
Percentage of Participants with UPCR < 0.3 and estimated glomerular filtration rate (eGFR) decline ≤ 15% from baseline
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 2 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant Humanized Monoclonal Antibody MIL62 Injection in people with Lupus Nephritis, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects achieving complete renal remission (CRR) at 76 weeks (time frame: week 76). 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 2 Jul 2025.