Could CAR-T cells tame tough lupus kidney disease?
NCT ID NCT05938725
First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 3 times
Summary
This early-phase trial is testing a new treatment called KYV-101, which uses a patient's own modified immune cells (CAR-T cells) to target and destroy faulty B cells that drive lupus kidney inflammation. The study involves 6 adults with lupus nephritis that hasn't responded to standard therapies. Researchers are primarily checking for safety and side effects, while also looking for signs that the treatment can improve kidney function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KYV-101 anti-CD19 CAR-T cell therapy
- What this could lead to
- If successful, this could point toward a new treatment option for people with hard-to-treat lupus kidney disease, potentially reducing the need for long-term immunosuppression.
- What could go wrong
- This is a very early, small trial with only 6 participants, so results may not apply widely. CAR-T therapy carries risks like severe immune reactions and infections.
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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6 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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May 2026
- 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
-
18 years and older
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years 2. Clinical diagnosis of SLE according to 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria 3. Biopsy-proven proliferative LN Class III or IV according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria 4. Positive anti-nuclear antibody (ANA) (titer ≥1:80 ), anti-dsDNA (≥30 IU/mL on enzyme-linked immunosorbent assay \[ELISA\]), or anti-Smith at screening or by documented medical history 5. Up to date on recommended vaccinations, including against coronavirus disease 2019 (COVID-19)/ severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), per Centers for Disease Control and Prevention (CDC) or institutional guidelines for immune compromised individuals Exclusion Criteria: 1. Rapidly progressive glomerulonephritis; history of or currently active severe central nervous system (CNS) lupus, including cerebritis, cerebrovascular accident, and seizures 2. Prior treatment with cellular immunotherapy (CAR-T) or gene therapy product directed at any target 3. History of allogeneic or autologous stem cell transplant 4. Evidence of active hepatitis B or hepatitis C infection 5. Positive serology for HIV 6. Primary immunodeficiency 7. History of splenectomy 8. History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject 9. Impaired cardiac function or clinically significant cardiac disease 10. Previous or concurrent malignancy with the following exceptions: 1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening) 2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening 3. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening
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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.
Contacts and locations
Locations
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Northwell Health
Great Neck, New York, 11021, United States
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Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
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Stanford University Medical Center
Palo Alto, California, 94305, United States
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University of Colorado
Denver, Colorado, 80045, United States
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University of Massachusetts Worcester
Worcester, Massachusetts, 01655, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 5,000-Patient registry aims to map the Long-Term course of lupus nephritis
- Can a blood test catch lupus flares earlier?
- Can a single CAR-T infusion reset the immune system and stop lupus kidney damage?
- Blood markers may foretell kidney trouble in lupus
- Can bone marrow stem cells calm lupus kidney flares?
- Can a targeted antibody boost kidney remission in lupus?