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

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

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

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

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

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

Immunology

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

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

Kyverna Therapeutics Announces Positive Topline Data from Registrational KYSA-8 Trial of Miv-cel (KYV-101) in Stiff Person Syndrome (GlobeNewswire) - "A total of 26 patients were dosed and followed through the primary analysis time point (Week 16)....Miv-cel demonstrated a robust and sustained improvement in mobility with a highly statistically significant improvement in timed 25-foot walk (T25FW) (p=0.0002). The median improvement was 46% at Week 16 as compared to baseline. 81% of patients exceeded a 20% improvement in T25FW, a threshold considered clinically meaningful. Secondary Endpoints: highly statistically significant benefit (all p-values <0.0001) was also achieved across all secondary endpoints....Based on these data, Kyverna plans to submit a Biologics License Application (BLA) to the FDA for SPS in the first half of 2026....The Company also plans to share the full SPS data set at a medical conference in 2026."

FDA filing • P2 data • CNS Disorders • Immunology • Rare Diseases

KYSA-8: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Treatment Refractory Stiff Person Syndrome (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Kyverna Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders

Kyverna Therapeutics…announced it will host a live webcast and conference call on Monday, December 15, 2025 at 8:00 am ET to review topline results from the registrational Phase 2 KYSA-8 clinical trial evaluating KYV-101 in stiff person syndrome (SPS) (GlobeNewswire)

P2 data • CNS Disorders • Rare Diseases

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