mivocabtagene autoleucel (KYV-101) / Kyverna - LARVOL DELTA

Neutrophil transcriptomics in SLE reveals intrinsic disease signatures, shared ex vivo adaptation, and transcriptional reset after CAR T-cell therapy. (PubMed, Ann Rheum Dis) - "Neutrophils in SLE exhibit intrinsic, disease-specific transcriptomic alterations while sharing ex vivo adaptation dynamics with healthy individuals. The disease-specific alterations appear to be modifiable through targeted therapeutic intervention, as anti-CD19 CAR T-cell therapy resets neutrophil gene expression towards healthy patterns despite targeting B cells rather than neutrophils directly. These findings provide insights into SLE pathogenesis and highlight potential therapeutic strategies targeting both adaptive and innate immunity."

Journal • Preclinical • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Emerging Efficacy and Safety of Mivocabtagene Autoleucel, a Fully Human CD19 CAR T-Cell Therapy, in Severe Autoimmune Rheumatic Diseases (EULAR 2026) - No abstract available

CAR T-Cell Therapy • Clinical • Immunology • Rheumatology

Multimodal Phenotyping of B-Cell Depletion and Reconstitution Following CD19 CAR T-Cell Therapy with Mivocabtagene Autoleucel in ACPA-Positive, Treatment-Refractory, Active Rheumatoid Arthritis - Data from the Phase 1 of the Prospective, Interventional COMPARE Trial (EULAR 2026) - No abstract available

CAR T-Cell Therapy • Clinical • P1 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

SAFETY AND EMERGING CLINICAL IMPACT OF CD19 CAR T-CELL THERAPY IN SEVERE AUTOIMMUNE RHEUMATIC DISEASES: A SINGLE-CENTRE CASE SERIES (EBMT 2026) - "All patients received lymphodepletion (mainly fludarabine/cyclophosphamide; dose-adjusted fludarabine for renal impairment; bendamustine as alternative in severe renal dysfunction) followed by a single KYV-101 infusion...All cases responded promptly to tocilizumab, and four patients received additional dexamethasone... In this cohort of patients with severe, treatment-refractory ARDs, KYV-101 induced rapid, profound B-cell depletion, leading to a durable, drug-free response with a manageable safety profile over ≥12 months. CRS events were uniformly low grade and controllable with early, protocolised intervention. Haematotoxicity, particularly neutropenia, including delayed episodes, represented a relevant component of the adverse event spectrum and responded to supportive care."

CAR T-Cell Therapy • Clinical • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Myositis • Nephrology • Neutropenia • Pneumonia • Rare Diseases • Renal Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

SAFETY AND EMERGING CLINICAL IMPACT OF CD19 CAR T-CELL THERAPY IN SEVERE AUTOIMMUNE RHEUMATIC DISEASES: A SINGLE-CENTRE CASE SERIES (EBMT 2026) - "All patients received lymphodepletion (mainly fludarabine/cyclophosphamide; dose-adjusted fludarabine for renal impairment; bendamustine as alternative in severe renal dysfunction) followed by a single KYV-101 infusion...All cases responded promptly to tocilizumab, and four patients received additional dexamethasone... In this cohort of patients with severe, treatment-refractory ARDs, KYV-101 induced rapid, profound B-cell depletion, leading to a durable, drug-free response with a manageable safety profile over ≥12 months. CRS events were uniformly low grade and controllable with early, protocolised intervention. Haematotoxicity, particularly neutropenia, including delayed episodes, represented a relevant component of the adverse event spectrum and responded to supportive care."

CAR T-Cell Therapy • Clinical • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Myositis • Nephrology • Neutropenia • Pneumonia • Rare Diseases • Renal Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Design of Phase Three of KYSA-6, a Global Open-label, Randomized, Controlled Study of KYV-101, a Fully Human CD19 Chimeric Antigen Receptor (CAR) T-cell Therapy, Versus Ongoing Standard-of-Care (SOC) Immunosuppressive Therapy in Generalized Myasthenia Gravis (gMG) (AAN 2026) - P2/3 | "KYV-101 is a novel therapy with the potential to change the treatment paradigm through deep B-cell depletion and immune reset with a single dose in patients with autoimmune diseases. The phase 3 portion of KYSA-6 is intended as a registrational study for patients with gMG."

Clinical • CNS Disorders • Immunology • Myasthenia Gravis

KYV101-004: Not Applicable (clinicaltrialsregister.eu) - P2/3 | N=30 | Not yet recruiting | Sponsor: Kyverna Therapeutics Inc.

New P2/3 trial • CNS Disorders • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myasthenia Gravis • Nephrology • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis

Update on the Phase Two Portion of KYSA-6, an Open-label, Single-arm, Multicenter Study of KYV-101, a Fully Human CD19 Chimeric Antigen Receptor (CAR) T-cell Therapy in Generalized Myasthenia Gravis (gMG) (AAN 2026) - P2/3 | "These findings support the potential of KYV-101 to deliver durable, drug-free, disease-free remission in patients with moderate to severe MG. KYV-101 treatment resulted in robust and sustained improvements in disease severity with an acceptable safety profile, while eliminating background immunosuppressants in the majority of patients. Phase 3 is ongoing; updated phase 2 follow-up will be presented."

Clinical • CNS Disorders • Immunology • Myasthenia Gravis

Miv-cel CD19 CAR T-Cell Therapy Shows Efficacy and Safety in Stiff Person Syndrome in a Pivotal, Multicenter, Phase 2 Study (KYSA-8) (AAN 2026) - No abstract available

CAR T-Cell Therapy • Clinical • Late-breaking abstract • P2 data • CNS Disorders

Industry Therapeutic Update from Kyverna: Miv-cel CD19 CAR T: Reimagining Treatment for Neurologic Autoimmune Diseases (AAN 2026) - "Learning Objectives This symposium will examine the rationale for CD19-directed CAR T-cell therapies in B cell–driven neurologic autoimmune diseases. Attendees will review emerging clinical data from miv-cel (mivocabtagene autoleucel, formerly KYV-101), an investigational CD19 CAR T-cell therapy, and discuss key considerations relevant to CAR T-cell therapy in neuroautoimmune populations, with a focus on stiff person syndrome and myasthenia gravis."

CNS Disorders • Immunology • Myasthenia Gravis

A Multicenter, Real-world Natural History Study on Timed 25-foot Walk Outcome Measures in Stiff Person Syndrome (AAN 2026) - "This study represents the largest real-world natural history study to date examining the impact of SPS on walking speed. T25FW appears to be a clinically meaningful outcome measure in SPS, capturing key aspects of functional impairment. Ambulatory outcome measures may support the development of new therapies, including KYV-101, addressing a critical unmet need for patients with SPS."

Clinical • Real-world • Real-world evidence • CNS Disorders • Immunology

COMPARE: Comparison of B-cell Depletion by Rituximab and Anti-CD 19 CAR-T Therapy in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1/2 | N=13 | Active, not recruiting | Sponsor: Charite University, Berlin, Germany | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Mar 2027 ➔ Jun 2027 | Trial primary completion date: Mar 2027 ➔ Jun 2027

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Industry Therapeutic Update from Kyverna: Miv-cel CD19 CAR T: Reimagining Treatment for Neurologic Autoimmune Diseases? (AAN 2026) - "Sponsored by Kyverna."

Immunology

Kyverna Therapeutics to Present New Data from Neuroimmunology Franchise at AAN 2026 (GlobeNewswire) - "Late-breaking oral presentation to feature primary analysis from KYSA-8 registrational trial in stiff person syndrome (SPS). Oral presentation on updated KYSA-6 Phase 2 data in generalized myasthenia gravis (gMG)."

Late-breaking abstract • P2 data • Immunology • Myasthenia Gravis

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Stanford University | Active, not recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Multiple Sclerosis

CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: David Porter | Trial completion date: Feb 2026 ➔ Feb 2027 | Trial primary completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Myositis • Nephrology • Scleroderma • Systemic Sclerosis • Vasculitis • IFIH1 • KRAS • TRIM33

KYSA-4: A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101 (clinicaltrials.gov) - P=N/A | N=70 | Recruiting | Sponsor: Kyverna Therapeutics

New trial • CNS Disorders • Dermatomyositis • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Multiple Sclerosis • Myositis • Nephrology • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis

An Investigator Initiated Study of KYV 101, a CD19 CAR T Cell Therapy, in Participants with Treatment Refractory Progressive Multiple Sclerosis (ACTRIMS Forum 2026) - "This study addresses the unmet need for effective therapies in progressive MS. Early results suggest anti-CD19 CAR-T cell therapy is safe in MS patients and penetrate the CSF effectively. We have further noted stabilization of EDSS scores despite their prior progression in our 2 participants."

CAR T-Cell Therapy • IO biomarker • CNS Disorders • Inflammation • Multiple Sclerosis

Chimeric Antigen Receptor T Cell (CAR-T) Immunotherapy for ProgressivePhenotypes of Multiple Sclerosis: ongoing results from a prospective Phase 1, Open-Label, Single CenterStudy of an Autologous Fully-Human Anti-CD19 CAR-T (ACTRIMS Forum 2026) - "Two experienced transient shingles reactivation, resolving with oral acyclovir. Autologous CD19-directed CAR T-cell therapy (KYV-101) in progressive MS was feasible, well tolerated, and induced profound yet reversible B-cell depletion. B cell reconstitution skewed strongly toward a naïve phenotype. Early clinical signals included improved fatigue, iADLs, and EDSS, with varied intrathecal biomarker shifts."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • CNS Disorders • Hematological Disorders • Herpes Zoster • Infectious Disease • Inflammation • Multiple Sclerosis • Pneumonia • Tetanus • Varicella Zoster • CD27

Cytokine Profiling in a Phase 1 Study of Autologous Fully-Humanized Anti-CD19 Chimeric Antigen Receptor T Cell (CAR-T) Immunotherapy for Progressive Phenotypes of Multiple Sclerosis (ACTRIMS Forum 2026) - "This study aims to assess the early cytokine profiles of patients with progressive MS receiving CAR-T therapy with a CD19+ single chain variable fragment (scVf), to better understand the immunologic effects of CART-T immunotherapy. Patients with progressive MS (ages 18-65, EDSS 3.0-7.0) were enrolled in a phase 1, open label single center study of autologous fully human anti-CD19 CAR-T immunotherapy (KYV-101, Kyverna Therapeutics) and underwent apheresis, bendamustine lymphodepletion, and CAR-T administration in a dose ranging 3 X 3 study design. Early cytokine profiling demonstrates the impact of anti-CD19 CAR-T therapy on the immune system of patients with progressive MS. In our first 4 treated subjects, CAR-T infusion induced a transient cytokine storm peaking at Days 7-14, with immune activation subsiding quickly after the CAR-T peak. By Day 28, pro-inflammatory cytokines (including many important to MS pathogenesis) showed broad suppression toward or below baseline."

CAR T-Cell Therapy • P1 data • CNS Disorders • Inflammation • Multiple Sclerosis • CCL2 • CSF2 • CXCL10 • CXCL9 • IFNG • IL6 • TNFA

Update on the Phase 2 Part of Kysa-6, an Open-Label, Single-Arm, Multicenter Study of Kyv-101, a Fully Human CD19 Chimeric Antigen Receptor T-cell Therapy in Generalized Myasthenia Gravis (TCT-ASTCT-CIBMTR 2026) - P2/3 | "Phase 2 results will provide early evidence for the potential of KYV-101 in gMG, to be confirmed in an ongoing phase 3 trial. Define the unmet need for novel therapies in gMG that can minimize or eliminate symptoms of disease while reducing risks associated with ongoing immunosuppression Understand the unique features of KYV-101, a fully human CAR T-cell therapy with CD28 costimulation designed for potency and tolerability, and its rationale for use in gMG Describe early efficacy and safety results from the phase 2 portion of the KYSA-6 clinical study of KYV-101 in gMG"

CAR T-Cell Therapy • Clinical • P2 data • CNS Disorders • Immunology • Myasthenia Gravis

Initiated Phase 3 registrational trial in gMG: In December 2025, Kyverna enrolled its first patient in the Phase 3 portion of the FDA-aligned KYSA-6 clinical trial of miv-cel (mivocabtagene autoleucel, KYV-101) in gMG. (GlobeNewswire)

Enrollment open • Myasthenia Gravis

Evaluate additional pipeline opportunities in a capital-efficient manner (GlobeNewswire) - "In 2026, the Company expects to report Phase 2 investigator-initiated trial (IIT) data in rheumatoid arthritis, additional Phase 1 IIT data in multiple sclerosis, Phase 1 data in lupus nephritis and share the development strategy for KYV-102. Further, Kyverna will continue to explore miv-cel with​ no lymphodepletion (LD) or alternative LD regimen as well as outpatient administration."

Clinical • P1 data • P2 data • Immunology • Lupus Nephritis • Multiple Sclerosis • Rheumatoid Arthritis

A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: Bruce Cree | Trial completion date: Jun 2027 ➔ Feb 2027 | Trial primary completion date: Jun 2026 ➔ Feb 2026

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

CAR-engineered cell therapies: current understandings and future perspectives. (PubMed, Mol Biomed) - "Trials like KYV-101 for multiple sclerosis demonstrate continued progress and the potential of these therapies to translate into clinical practice. Overall, CAR-engineered treatments enable precise, programmable immune modulation, paving the way for advanced therapies across an expanding array of diseases."

Journal • Review • CNS Disorders • Fibrosis • Hematological Disorders • Human Immunodeficiency Virus • Immune Modulation • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Multiple Sclerosis • Oncology • Rheumatoid Arthritis • Rheumatology • Solid Tumor • Transplantation