New shot aims to calm immune attack on kidneys
NCT ID NCT05668403
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new drug called B007, given as a shot under the skin, for people with primary membranous nephropathy — a kidney disease where the immune system attacks the kidneys. The study will include 52 adults and will focus on safety, how the drug moves through the body, and whether it shows any early signs of helping. Because it is a Phase 1 trial, the main goal is to find a safe dose, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- B007 (a lab-made antibody that targets CD20 on immune cells)
- What this could lead to
- If it works, this could point toward a new treatment option for primary membranous nephropathy that is easier to take (as a shot under the skin).
- What could go wrong
- This is a very early Phase 1 trial with only 52 people, focused on safety and dosing. It is too soon to know if the drug will actually help the disease, and there may be side effects from targeting immune cells.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects who have fully understood this study and voluntarily signed the informed consent form; 2. Male or female subjects, aged between 18 and 75 years; 3. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy; 4. Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening; 5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required; 6. Subjects who are able to follow the study protocol as judged by the investigator. Exclusion Criteria: 1. Subjects with secondary membranous nephropathy; 2. Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening; 3. Subjects with decreases in urine protein ≥ 50% within 6 months before screening; 4. Subjects who have received or are receiving renal replacement therapy; 5. Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy; 6. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment; 7. Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy; 8. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies; 9. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug; 10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug; 11. Subjects with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator; 12. Subjects with a history of alcoholism or drug abuse within 12 months; 13. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency; 14. Subjects with CD4+ T lymphocyte count \< 300 cells/μL; 15. Other conditions unsuitable for participation in this study determined by the Investigator.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Hebei General Hospital
RECRUITINGShijiazhuang, Hebei, 050057, China
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Longhua Hospital Shanghai University of Traditional Chinese Medicine
RECRUITINGShanghai, 200032, China
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Longhua Hospital Shanghai University of Traditional Chinese Medicine
RECRUITINGShanghai, 200032, China
Contact Email: •••••@•••••
Contact Email: •••••@•••••
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Peking university first hospital
RECRUITINGBeijing, 100010, China
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The First Affiliated Hospital of Zhengzhou University
RECRUITINGZhengzhou, He'nan, 410100, China
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The First Affiliated Hospital,College of Medicine,Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310003, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A new tool to predict kidney failure risk in membranous nephropathy?
- Can engineered immune cells tackle a tough kidney disease?
- Can a smarter antibody outsmart a kidney disease that resists standard treatment?
- Can engineered immune cells tame autoimmune kidney disease?
- Can a pill calm the immune attack on kidneys?
- Can a gene-silencing drug calm overactive complement in kidney disease?