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

Phase 1

Recruiting

• Conditions: Systemic Sclerosis - Diffuse Cutaneous; Systemic Sclerosis; Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
• Interventions: Biological: KYV-101; Drug: Standard lymphodepletion regimen

• Registration Number: NCT06400303
• Lead Sponsor: Kyverna Therapeutics

Brief 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.

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2024-05-01
• Study First Posted: 2024-05-06
• Status Verified: 2024-08
• Study Start: 2024-08-06
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2026-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1)	KYV-101	Dosing with KYV-101 CAR T cells
KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2)	Standard lymphodepletion regimen	Recommended Phase 2 Dose
KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1)	Standard lymphodepletion regimen	Dosing with KYV-101 CAR T cells
KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2)	KYV-101	Recommended Phase 2 Dose

Primary Outcome Measures

Name	Time	Method
Frequency of Dose-Limiting Toxicities (DLTs) at each dose level (Phase 1)	Up to 2 years
Incidence of adverse events and laboratory abnormalities (Phase 1)	Up to 2 years
To evaluate efficacy of KYV-101(Phase 2)	52 weeks	via revised Composite Response Index in Systemic Sclerosis (rCRISS) 30/5

Secondary Outcome Measures

Name	Time	Method
To evaluate efficacy of KYV-101 (Phase 1 and Phase 2)	12, 24, 52 weeks	revised Composite Response Index in Systemic Sclerosis (rCRISS) 30/5 response rate
To evaluate pharmacodynamics (PK) of KYV-101 in blood (Phase 1 and Phase 2)	Up to 2 years	Chimeric antigen receptor-positive (CAR-positive) T-cell counts in blood
To evaluate pharmacodynamics (PD) of KYV-101 in blood (Phase 1 and Phase 2)	Up to 2 years	Levels of cytokines in serum
To evaluate immunogenicity (humoral response) of KYV-101 (Phase 1 and Phase 2)	Up to 2 years	Percentage of participants who develop anti-KYV-101 antibodies by immunoassays
To define the Recommended Phase 2 Dose (RP2D) (Phase 1)	Up to 2 years

Trial Locations

Locations (2)

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

Northwell Health; 🇺🇸 Great Neck, New York, United States