A Phase 1/2 interventional study of KYV-101 and Standard lymphodepletion regimen in Systemic Sclerosis, Systemic Sclerosis - Diffuse Cutaneous and Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria, sponsored by Kyverna Therapeutics. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Kyverna Therapeutics · Phase 1/2, Interventional, and Treatment
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis
SSc is an immune-mediated rheumatic disease that is characterized by fibrosis of the skin and internal organs and vasculopathy. B-cells play a role in SSc, and the disease is characterized by the presence of autoantibodies such as anti-Scl-70 and anti-RNAP III antibodies. CD19-targeted chimeric antigen receptor (CAR) T-cells harness the ability of cytotoxic T-cells to directly and specifically lyse target cells to effectively deplete B-cells in the circulation and in lymphoid and potentially non-lymphoid tissues. KYV-101, a fully human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with systemic sclerosis.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 3 is below the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Kyverna Therapeutics is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Key Inclusion Criteria
Key Exclusion Criteria
Previous or concurrent malignancy with the following exceptions:
Dosing with KYV-101 CAR T cells
Biological: KYV-101 · Drug: Standard lymphodepletion regimen
Recommended Phase 2 Dose
Biological: KYV-101 · Drug: Standard lymphodepletion regimen
Anti-CD19 CAR-T cell therapy
Standard lymphodepletion regimen
Also known as: Cyclophosphamide, Fludarabine
Incidence of adverse events and laboratory abnormalities (Phase 1)
Time frame: Up to 2 years
Frequency of Dose-Limiting Toxicities (DLTs) at each dose level (Phase 1)
Time frame: Up to 2 years
To evaluate efficacy of KYV-101(Phase 2)
via revised Composite Response Index in Systemic Sclerosis (rCRISS) 30/5
Time frame: 52 weeks
To evaluate pharmacodynamics (PK) of KYV-101 in blood (Phase 1 and Phase 2)
Chimeric antigen receptor-positive (CAR-positive) T-cell counts in blood
Time frame: Up to 2 years
To evaluate pharmacodynamics (PD) of KYV-101 in blood (Phase 1 and Phase 2)
Levels of B-cells in blood
Time frame: Up to 2 years
To evaluate pharmacodynamics (PD) of KYV-101 in blood (Phase 1 and Phase 2)
Levels of cytokines in serum
Time frame: Up to 2 years
To evaluate efficacy of KYV-101 (Phase 1 and Phase 2)
revised Composite Response Index in Systemic Sclerosis (rCRISS) 30/5 response rate
Time frame: 12, 24, 52 weeks
To evaluate immunogenicity (humoral response) of KYV-101 (Phase 1 and Phase 2)
Percentage of participants who develop anti-KYV-101 antibodies by immunoassays
Time frame: Up to 2 years
To define the Recommended Phase 2 Dose (RP2D) (Phase 1)
Time frame: Up to 2 years
Plan to share: No
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Kyverna Therapeutics