Anti-CD19 CAR T-cell therapy for refractory lupus nephritis
KYSA-3: A Phase 1/2, Open-Label, Multicenter Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
This study is testing a new type of CAR T-cell therapy to see if it can help adults with hard-to-treat lupus nephritis feel better when other treatments haven't worked.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kyverna Therapeutics Industry-sponsored |
| Drugs / interventions | CAR-T, Chimeric Antigen Receptor, CAR T |
| Locations | 6 sites (Berlin and 5 other locations) |
| Trial ID | NCT06342960 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of KYV-101, an anti-CD19 chimeric antigen receptor T-cell therapy, in adults suffering from refractory lupus nephritis, a severe manifestation of systemic lupus erythematosus. The approach aims to deplete pathogenic B cells that contribute to the disease's progression by utilizing CAR T-cells that specifically target CD19. Participants will undergo a standard lymphodepletion regimen prior to receiving the therapy. The study is designed to assess the safety and efficacy of this innovative treatment in a population that has not responded to conventional therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical diagnosis of systemic lupus erythematosus and biopsy-proven proliferative lupus nephritis Class III or IV.
Not a fit: Patients with rapidly progressive glomerulonephritis or severe central nervous system lupus may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with refractory lupus nephritis, potentially improving kidney function and overall disease management.
How similar studies have performed: While CAR T-cell therapies have shown promise in other autoimmune conditions and malignancies, this specific application for lupus nephritis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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/ severe acute respiratory syndrome coronavirus 2 (Covid-19/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 therapy (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
Where this trial is running
Berlin and 5 other locations
- Charite- Universitätsklinikum Berlin — Berlin, Germany (Recruiting)
- Universitätsklinikum Carl Gustav Carus Dresden — Dresden, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Recruiting)
- Universitätsklinikum Erlangen — Erlangen, Germany (Recruiting)
- Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP — Frankfurt, Germany (Recruiting)
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
Study contacts
- Study coordinator: Kyverna Therapeutics
- Email: clinicaltrials@kyvernatx.com
- Phone: 510-925-2484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.