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Standard lymphodepletion regimen

DRUG8 trials

Sponsors

Kyverna Therapeutics, Stanford University, Arcellx, Inc.

Conditions

AutoimmuneAutoimmune DiseasesAutoimmune Diseases of the Nervous SystemGeneralized Myasthenia GravisLupus NephritisLupus Nephritis - WHO Class IIILupus Nephritis - WHO Class IVLupus Nephritis - World Health Organization (WHO) Class III

Phase 1

KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
Active, not recruitingNCT05938725
Kyverna TherapeuticsLupus Nephritis, Lupus Nephritis - WHO Class IV, Lupus Nephritis - World Health Organization (WHO) Class III
Start: 2023-04-28End: 2027-08-31Updated: 2025-10-29
A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis
RecruitingNCT06138132
Stanford UniversityMultiple Sclerosis, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
Start: 2024-04-10End: 2027-06-01Target: 12Updated: 2026-02-27
KYSA-3: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
Active, not recruitingNCT06342960
Kyverna TherapeuticsLupus Nephritis, Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV
Start: 2022-12-01End: 2029-01-31Updated: 2025-10-29
KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis
Active, not recruitingNCT06400303
Kyverna TherapeuticsSystemic Sclerosis, Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria, Systemic Sclerosis - Diffuse Cutaneous
Start: 2024-08-06End: 2027-03-31Updated: 2025-10-08
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
RecruitingNCT06626919
Arcellx, Inc.Autoimmune, Autoimmune Diseases, Autoimmune Diseases of the Nervous System +4
Start: 2025-04-30End: 2028-04-01Target: 30Updated: 2026-02-25

Phase 2

KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis
RecruitingNCT06193889
Kyverna TherapeuticsGeneralized Myasthenia Gravis, Myasthenia Gravis
Start: 2024-08-28End: 2028-09-01Target: 66Updated: 2026-01-30
KYSA-7: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis
Active, not recruitingNCT06384976
Kyverna TherapeuticsMS, Multiple Sclerosis, Multiple Sclerosis, Primary Progressive +1
Start: 2024-09-20End: 2029-01-31Target: 120Updated: 2025-01-13
KYSA-8: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Treatment Refractory Stiff Person Syndrome
Active, not recruitingNCT06588491
Kyverna TherapeuticsSPS, Stiff-Person Syndrome
Start: 2024-09-25End: 2026-12-31Target: 25Updated: 2025-12-22

Related Papers

Chimeric antigen receptor T-cell therapy for stiff-person syndrome: bridging innovation and clinical challenges in neuroimmunology.
2025-11-10
CAR T cells for multiple sclerosis: Engineering T cells to disrupt chronic B cell-driven neuroinflammation.
2025-10-261 citations
P95 First two US patients with lupus nephritis (LN) treated with anti-CD19 chimeric antigen receptor (CAR) T-cell therapy: preliminary results from the KYSA-1 phase 1, multicenter study of KYV-101
Poster presentations2024-03-015 citations