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New shot aims to calm immune attack on kidneys

NCT ID NCT05668403

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • Hebei General Hospital

    RECRUITING

    Shijiazhuang, Hebei, 050057, China

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    RECRUITING

    Shanghai, 200032, China

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    RECRUITING

    Shanghai, 200032, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Peking university first hospital

    RECRUITING

    Beijing, 100010, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, He'nan, 410100, China

  • The First Affiliated Hospital,College of Medicine,Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

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