KYV-101 / Kyverna - LARVOL DELTA

Successful autologous CD19 CAR T cell therapy following severe lupus flare during immunosuppressive washout in refractory lupus nephritis. (PubMed, Lupus Sci Med) - "This case report illustrates that targeted pulse corticosteroids during CAR T cell therapy washout can effectively manage severe lupus flares without impairing therapeutic efficacy."

Journal • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rheumatology • Systemic Lupus Erythematosus

Kyverna Therapeutics Provides Business Update… (GlobeNewswire) - "Anticipated Milestones: (i) MG: Report updated data for the Phase 2 portion of KYSA-6 Phase 2/3 trial data in 2026; Initiate enrollment for registrational Phase 3 trial by year-end 2025; (ii) Additional Indications: Lupis Nephritis: Report Phase 1 data in a peer-reviewed publication in 2026."

Clinical data • Trial status • Lupus Nephritis • Myasthenia Gravis

Anticipated Milestones:…SPS (GlobeNewswire) - "(i) Report topline registrational KYSA-8 Phase 2 data in early 2026; (ii) BLA filing in 1H 2026."

FDA filing • P2 data • Immunology • Rare Diseases

A Study of Kyv-101, a CD19 CAR T Cell Therapy, in Participants with Treatment Refractory Progressive Multiple Sclerosis (ASH 2024) - P1 | "Currently approved treatments include siponimod, an S1P receptor modulator, and ocrelizumab, an anti-CD20 monoclonal antibody...After apheresis and CAR T-cell production, participants will receive standard lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single infusion of KYV-101 at one of two dose levels...The study is expected to complete in 2026. MRS and SG contributed equally to the work"

CAR T-Cell Therapy • CNS Disorders • Multiple Sclerosis

CD19-Directed CAR T Cell Therapy in 4 Patients with Refractory Multiple Sclerosis (ASH 2024) - "A single dose of 1 x 108 second-generation anti-CD19-directed CAR T cells (KYV-101, Kyverna Therapeutics) was administered following lymphodepletion with fludarabine (30 mg/m2 on day -5, -4, -3) and cyclophosphamide (300 mg/m2 on day -5, -4, -3)...After CAR T infusion 3 of the 4 patients experienced reoccurring CRS grade 1 requiring treatment with tocilizumab, dexamethasone or anakinra...Short term follow-up indicates temporary target effects with at the same time signs of new inflammation in MRI imaging as well as clinical progression in one patient although long term data is needed. Further data will be presented."

CAR T-Cell Therapy • Clinical • CNS Disorders • Hematological Disorders • Immunology • Inflammation • Multiple Sclerosis • Neutropenia

CAR T cells for multiple sclerosis: Engineering T cells to disrupt chronic B cell-driven neuroinflammation. (PubMed, Mult Scler Relat Disord) - P1 | "These include the first-in-human trial CT103A (BCMA-targeted CAR T) in progressive MS and NMOSD (NCT04561557), the detection of CAR T cells in the CNS without ICANS in Anti-CD19 CAR T therapy (NCT06138132), the favorable safety in the multicenter study BMS986353 (NCT06220201), and the confirmed CNS penetration in the UCSF's KYV-101, a CD19 CAR T Cell Therapy study (NCT06451159). However, key challenges remain: the absence of validated CNS-specific antigens, risks such as ICANS, delayed parkinsonian-like syndromes, or progressive multifocal leukoencephalopathy (PML), immune exhaustion within the inflamed CNS, and the logistical demands of autologous cell manufacture. This mini-review synthesizes preclinical and early clinical evidence, outlines translational barriers, and discusses strategies to optimize safety, targeting, and scalability."

Clinical • Journal • Review • CNS Disorders • Immunology • Inflammation • Movement Disorders • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Parkinson's Disease • Rare Diseases

KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (clinicaltrials.gov) - P1/2 | N=6 | Active, not recruiting | Sponsor: Kyverna Therapeutics | N=32 ➔ 6 | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2025 ➔ Aug 2026 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

KYSA-3: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (clinicaltrials.gov) - P1/2 | N=2 | Active, not recruiting | Sponsor: Kyverna Therapeutics | Recruiting ➔ Active, not recruiting | N=32 ➔ 2

Enrollment change • Enrollment closed • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

An Open-label, Randomized, Controlled Phase 1/2 Study to Assess the Safety and Efficacy of KYV-101 anti-cd19 CAR-T Cell Therapy in Active and Difficult-to-treat ACPA Positive Rheumatoid Arthritis: Preliminary Results of the COMPARE Trial (ACR Convergence 2025) - "The COMPARE (COMparison of B-cell dePletion by rituximAb and anti-CD 19 CAR-T therapy in Patients with rhEumatoid arthritis) trial was designed to (i) evaluate the safety and efficacy of the anti-CD19 CAR-T cell therapy KYV-101 in ACPA-positive patients with active, treatment refractory D2T-RA and (ii) to compare the impact of KYV-101 on disease activity to the standard-of-care anti-CD20 monoclonal antibody rituximab (RTX)...Both treated participants experienced expected transient cytopenias due to lymphodepletion and CRS (grade I and II), which promptly resolved following tocilizumab and dexamethasone administration... Preliminary data from the COMPARE trial suggest that KYV-101 has a favorable safety profile and leads to robust CAR T-cell expansion and complete peripheral B-cell depletion in seropositive, active, treatment refractory D2T-RA. With apheresis completed and planned KYV-101 infusion for all Phase 1 patients by July 2025 completion of safety run-in is..."

CAR T-Cell Therapy • Clinical • P1/2 data • Hematological Disorders • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Kyverna Therapeutics Announces Positive Interim Phase 2 Data from KYSA-6 Study of KYV-101 in Generalized Myasthenia Gravis at AANEM 2025 (GlobeNewswire) - "As of the October 3, 2025 data cut-off, six patients with moderate to severe gMG (mean MG-ADL 11.2, QMG 17.3, MGC 21.8), and an average disease duration of 5.3 years (1.7-13.3) were treated with a single dose of 1×108 KYV-101 CAR+T cells...100% (6/6) of patients achieved clinically meaningful2, robust, rapid, and sustained reductions in MG-ADL and QMG scores from baseline regardless of prior biologic exposure; The mean reductions of MG-ADL and QMG scores were -8.0 points and -7.7 points at 24 weeks, respectively, with deep responses seen as early as two weeks; 100% (6/6) of patients responded, achieving a ≥3-point reduction in both MG-ADL and QMG....KYV-101 was well-tolerated with no new safety signals observed."

P2 data • Immunology • Myasthenia Gravis

Kyverna Therapeutics Highlights Potential of KYV-101 in Rheumatoid Arthritis with Phase 1 Data from Investigator-Initiated Trial Presented at ACR Convergence 2025 (GlobeNewswire) - "With follow up ranging from 28 to 175 days, four out of six patients met the American College of Rheumatology 20% improvement criteria (ACR20) response, with two of these patients additionally achieving an ACR50 response (meeting 50% improvement thresholds)....These results supported the initiation of the randomized Phase 2 portion of the study, which is currently ongoing with patient enrollment completed."

P1 data • Trial status • Rheumatoid Arthritis

Kyverna Therapeutics…announced it will host a conference call on Wednesday, October 29, 2025 at 8:00 AM ET to discuss the interim data from the KYSA-6 Phase 2 clinical trial evaluating KYV-101 in generalized myasthenia gravis (gMG). (GlobeNewswire) - "This data will be shared at the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting taking place October 29 – November 1, 2025, in San Francisco, CA."

P2 data • Myasthenia Gravis

Neutrophil Transcriptomics in SLE: Exploring Intrinsic, Ex Vivo Adaptation, and CAR-T Cell Therapy-Induced Changes (ACR Convergence 2025) - "Additionally, longitudinal transcriptomic data from an SLE patient undergoing KYV-101 anti-CD19 CAR-T cell therapy were evaluated. We identified 258 differentially expressed genes (DEGs) consistently distinguishing SLE neutrophils from healthy controls regardless of the ex vivo culture duration; these genes spanned multiple clusters, enriched in upregulation of interferon-related and DNA damage repair genes, and downregulation of ribosomal protein genes... Neutrophils in SLE exhibit intrinsic, disease-specific transcriptomic alterations but also share certain ex vivo adaptation dynamics with healthy individuals across diverse biological pathways. Notably, anti-CD19 CAR-T cell therapy demonstrates a profound ability to reset neutrophil gene expression toward healthy patterns by three months post-treatment, despite targeting B cells rather than neutrophils directly. These findings provide insights into SLE pathogenesis and highlight potential therapeutic strategies..."

CAR T-Cell Therapy • IO biomarker • Preclinical • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis (clinicaltrials.gov) - P1/2 | N=3 | Active, not recruiting | Sponsor: Kyverna Therapeutics | Recruiting ➔ Active, not recruiting | N=21 ➔ 3

Enrollment change • Enrollment closed • Immunology • Scleroderma • Systemic Sclerosis

Anti-CD19 CAR T-Cell Therapy in Advanced Stiff-Person Syndrome and Concomitant Myasthenia Gravis. (PubMed, Neurol Neuroimmunol Neuroinflamm) - "CAR T-cell therapy was effective at mitigating SPS symptoms, despite the long history and severe refractory disease course in our patient. Controlled trials are needed to evaluate its potential in SPS."

Journal • CNS Disorders • Hematological Disorders • Infectious Disease • Inflammation • Leukopenia • Mood Disorders • Musculoskeletal Pain • Myasthenia Gravis • Pain • Psychiatry

Long-Term Remission with Anti-CD19 CAR T Cell Therapy in Refractory Myasthenia Gravis: A Two-Year Case Series (ECTRIMS 2025) - "Objectives/Aims: To evaluate the safety, immunological effects, and clinical efficacy of anti-CD19 CAR T cell therapy (KYV-101) in severe, treatment-resistant acetylcholine receptor antibody-positive MG patients, including one with comorbid rheumatoid arthritis... Anti-CD19 CAR T cell therapy induced durable clinical remission in refractory MG with an acceptable safety profile, even with persistent autoantibody titers. These results highlight the transformative potential of CAR T cell therapy in severe autoimmune neuromuscular diseases and justify further studies in larger patient cohorts. Disclousure of interest: Tobias Hegelmaier: nothing to disclose."

CAR T-Cell Therapy • Clinical • IO biomarker • Late-breaking abstract • CNS Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Myasthenia Gravis • Rheumatoid Arthritis • Rheumatology

An Investigator Initiated Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants with Treatment Refractory Progressive Multiple Sclerosis (ECTRIMS 2025) - "This study addresses the unmet need for effective therapies in progressive MS. Early results suggest CD19 CAR-T therapy may impact CNS pathology. Full data will be shared at the conference."

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

CD19-targeted CAR-T cell therapy in an anti Aquaporin-4 antibody positive NMOSD patient (ECTRIMS 2025) - "Thus, prevention of relapses is the mainstay of immunotherapy, and next to conventional immunosuppressants and rituximab, several therapeutic antibodies have been developed and approved specifically for this indication...Objectives/Aims: To describe the clinical course of a 61-year-old AQP4-antibody positive NMOSD patient treated with CD19-directed CAR-T cells (Kyverna KYV101) as an individual healing attempt. Beforehand, the patient had been treated with multiple immunomodulatory therapies including eculizumab, ravulizumab, satralizumab and inebilizumab...After leukapheresis in September 2024 and successful CAR T-cell production, lymphodepletion with cyclophosphamide and fludarabine was started on the 5th of December, 2024... The patient experienced grade 1 CRS, which was managed with paracetamol, IV fluids, and eventually tocilizumab. On day 11, the patient developed signs of ICANS, requiring a two-day stay in the ICU, steroids, and anakinra... CAR-T cell treatment in..."

CAR T-Cell Therapy • Clinical • CNS Disorders • Immunology • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Title: Chimeric Antigen Receptor T Cell (CAR-T) Immunotherapy for Progressive Phenotypes of Multiple Sclerosis: Early Results from a Phase 1, Open-Label, Single Center Study of an Autologous Fully Human Anti-CD19 CAR-T (GlobeNewswire) - "...Updated data...to be presented at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress....Stable to improved EDSS was observed in the three patients with six-month follow-up. Clinically meaningful improvement in fatigue scores was observed at the last follow-up (3-12 months) in three patients..."

P1 data • Multiple Sclerosis

Title: An Investigator Initiated Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants with Treatment Refractory Progressive Multiple Sclerosis (GlobeNewswire) - "...Updated data...to be presented at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress....Stable to improved EDSS scores were observed for both patients – one at 24 weeks of follow-up and another at 48-weeks of follow-up."

P1 data • Multiple Sclerosis

Kyverna Therapeutics to Highlight Interim Phase 2 Data from KYV-101 KYSA-6 Study in Myasthenia Gravis at AANEM 2025 (GlobeNewswire) - "The interim Phase 2 results that will be presented at AANEM will include top-line efficacy and safety data for six patients with up to nine months of follow-up. At the time the abstract was submitted, five patients had been dosed; the oral presentation will report on these patients as well as early data for a sixth patient who was dosed recently."

P2 data • Trial status • Myasthenia Gravis

CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: David Porter | Trial completion date: Aug 2028 ➔ Feb 2026 | Trial primary completion date: Aug 2028 ➔ Feb 2026

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

KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis (clinicaltrials.gov) - P2/3 | N=66 | Recruiting | Sponsor: Kyverna Therapeutics | Phase classification: P2 ➔ P2/3 | N=20 ➔ 66 | Trial completion date: May 2027 ➔ Sep 2028 | Trial primary completion date: May 2026 ➔ Sep 2027

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • CNS Disorders • Myasthenia Gravis

Kyverna Therapeutics Highlights Neuroimmunology CAR T Franchise and Registrational Phase 3 Trial Design in Myasthenia Gravis at Virtual KOL Event (GlobeNewswire) - "As part of this event, the Company will share...positive longer-term follow-up data from MG and SPS compassionate use patients treated with KYV-101..."

Clinical data • Clinical protocol • Myasthenia Gravis

Additional Indications: Multiple Sclerosis (MS) and Rheumatoid Arthritis (RA) (GlobeNewswire) - "Phase 1 IIT data of KYV-101 in MS to be showcased at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in September 2025, including an oral presentation on KYV-101 from Stanford University and a poster presentation from the University of California, San Francisco (UCSF); Phase 1/2 IIT data of KYV-101 in RA from Charité – University of Berlin to be highlighted at the American College of Rheumatology (ACR) Convergence 2025 meeting in October 2025."

P1 data • P1/2 data • Multiple Sclerosis • Rheumatoid Arthritis