NCT06400303

KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With 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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Kyverna Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis

Detailed description

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.

Conditions

• Systemic Sclerosis
• Systemic Sclerosis - Diffuse Cutaneous
• Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria

Interventions

Type	Name	Description
BIOLOGICAL	KYV-101	Anti-CD19 CAR-T cell therapy
DRUG	Standard lymphodepletion regimen	Standard lymphodepletion regimen

Timeline

• Start date: 2024-08-06
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2024-05-06
• Last updated: 2025-10-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study