Can engineered immune cells tackle a tough kidney disease?
NCT ID NCT07765537
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This trial is testing an experimental therapy called FKC289 for people with a type of kidney disease called primary membranous nephropathy that has come back or not responded to standard treatment. FKC289 uses the patient's own immune cells, which are modified in the lab to recognize and attack certain targets (BCMA and CD19) that may be driving the disease. The study aims to see if this approach is safe and whether it can reduce protein in the urine, a key sign of kidney damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FKC289, a type of CAR-T cell therapy using the patient's own immune cells engineered to target BCMA and CD19
- What this could lead to
- If successful, this could offer a new treatment option for people with membranous nephropathy that has not responded to standard therapies, potentially reducing protein in the urine and preserving kidney function.
- What could go wrong
- This is an early-stage trial (Phase I/II) with a small number of participants. CAR-T therapies can cause serious side effects, and it is unknown if this approach will be safe and effective for kidney disease.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
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 70 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. Voluntarily signed the informed consent form (ICF); 2. Aged between 18-70 years old (inclusive); 3. Histologically confirmed diagnosis of primary membranous nephropathy by renal biopsy obtained within the past 2 years.; 4. Relapsed or refractory disease; 5. Anti-PLA2R antibody \> 50 RU/mL; 6. 24-hour urine protein \> 3.5 g at screening; 7. No active systemic infection (e.g., infectious pneumonia, pulmonary tuberculosis) within 2 weeks prior to leukapheresis; 8. Adequate bone marrow and major organ function (including hepatic, renal, cardiac, and pulmonary); Exclusion Criteria: 1. Secondary membranous nephropathy or patients with a prior diagnosis of other renal diseases; 2. Presence of any clinically significant cardiovascular disease within 6 months prior to screening; 3. Clinically significant central nervous system (CNS) disease or pathological abnormality; 4. History of solid organ transplantation (e.g., heart, lung, kidney, liver); 5. Presence of complete intestinal obstruction; 6. Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage;
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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.
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The places running it
8 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
Locations
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Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, 210000, China
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Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
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Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
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Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
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Xiangya Hospital of Central South University
Changsha, Hunan, 410008, 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 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?
- New gel could outperform standard therapy for kidney disease