Anti-CD19 CAR T-cell therapy for systemic sclerosis
KYSA-5: A Phase 1/2, Open-Label, Multicentre Study of KYV 101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis
This study is testing a new treatment using CAR T-cell therapy to see if it can help adults with systemic sclerosis by targeting and reducing certain immune cells that contribute to the disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kyverna Therapeutics Industry-sponsored |
| Drugs / interventions | CAR-T, Chimeric Antigen Receptor, CAR T |
| Locations | 2 sites (Palo Alto, California and 1 other locations) |
| Trial ID | NCT06400303 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 diagnosed with systemic sclerosis (SSc). The approach focuses on targeting and depleting B-cells, which are implicated in the autoimmune processes of SSc. Participants will undergo a standard lymphodepletion regimen prior to receiving the CAR T-cell therapy. The study aims to evaluate the safety and efficacy of this innovative treatment in managing the symptoms and progression of systemic sclerosis.
Who should consider this trial
Good fit: Ideal candidates are adults with a clinical diagnosis of diffuse cutaneous systemic sclerosis who have active disease and meet specific inclusion criteria.
Not a fit: Patients with clinically significant interstitial lung disease or prior treatments involving cellular therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve outcomes for patients with systemic sclerosis by targeting the underlying autoimmune mechanisms.
How similar studies have performed: While CAR T-cell therapies have shown success in hematological malignancies, their application in systemic sclerosis is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria
1. Clinical diagnosis of SSc according to 2013 ACR/EULAR classification
2. Clinical disease as follows: Classified as diffuse cutaneous SSc; ≤ 6 years since first non-Raynaud's sign or symptom; active disease
3. Up to date on all recommended vaccinations per CDC or institutional guidelines for immune-compromised individuals
Key Exclusion Criteria
1. Clinically significant ILD
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
Palo Alto, California and 1 other locations
- Stanford University Medical Center — Palo Alto, California, United States (Recruiting)
- Northwell Health — Great Neck, New York, United States (Recruiting)
Study contacts
- Study coordinator: Kyverna Therapeutics, Inc.
- 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.