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

Longer-term Follow-Up Data in KYSA-6 Phase 2 Trial in gMG (GlobeNewswire) - "All 7 patients (100%) achieved clinically meaningful improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG), co-primary endpoints of the ongoing Phase 3 portion, at 24 weeks, with mean reductions of -8.3 and -11.7 points, respectively; Clinically meaningful improvements in MG-ADL, QMG and Myasthenia Gravis Composite (MGC) scores maintained through one year or longer in all five patients who have reached this time point; Minimal symptom expression...maintained in 57% of patients as of last follow up...Additional longer-term follow-up data from the Phase 2 portion of KYSA-6 will be shared in an oral presentation at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting on September 29, 2026, at 10:15 am EDT in Orlando, Florida...The Phase 3 portion of the KYSA-6 trial is ongoing, with enrollment expected to be completed in mid-2027."

Enrollment status • P2 data • Immunology • Myasthenia Gravis

Topline 12-month Data in KYSA-8 SPS Registrational Trial (GlobeNewswire) - "Significant timed 25-Foot Walk (T25FW) improvement sustained at month 12 (p 20% reduction from baseline) at the primary analysis sustained their benefit; Over one-third of patients completed T25FW in <5 seconds, comparable to a typical time for healthy adults; Of the 12 patients requiring a walking aid prior to treatment, 67% continue to not require assistance; Significant improvements in secondary endpoints remained consistent at 12 months (p values between <0.0001 and 0.0003)....Kyverna intends to include the one-year data in its rolling Biologics License Application (BLA) submission, which is on track to be completed in Q4 2026. The full data set will be presented at MS Toronto, the joint ACTRIMS-ECTRIMS meeting, taking place October 21–23, 2026, in Toronto, Canada."

FDA filing • P2 data • CNS Disorders • Immunology

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 | Terminated | Sponsor: Kyverna Therapeutics | Trial completion date: Jan 2029 ➔ Dec 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Oct 2028 ➔ Dec 2025; Study discontinued due to sponsor decision.

Trial completion date • Trial primary completion date • Trial termination • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

CD19 CAR T-Cell Therapy in Highly Treatment-Refractory Rheumatoid Arthritis: Phase 1 Results from the COMPARE Trial (ACR Convergence 2026) - "We evaluated the safety, clinical activity, and immunological effects of CD19 CAR T-cell therapy in the Phase 1 COMPARE trial. In the prospective Phase 1 of the open label Phase 1/2 COMPARE trial (EU CT: 2024-514955-13-00), six patients with active, ACPA-positive RA refractory to multiple biologic and targeted therapies received a single infusion of autologous CD19-directed CAR T cells (mivocabtagene autoleucel) following fludarabine/cyclophosphamide lymphodepletion...Patients were followed up for a median of 36 weeks (range 36-52). The cohort comprised six patients with long-standing, active, seropositive RA (median disease duration 9.6 years; median DAS28-CRP 5.5) and extensive prior treatment exposure (median 6.5 prior b/tsDMARDs), including rituximab in four patients... These Phase 1 data support the feasibility and safety of CD19 CAR T-cell therapy in highly treatment-refractory RA and provide early evidence of clinically meaningful activity, including..."

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

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

CAR T-Cell Therapy • Clinical • Immunology • Rheumatology

KYV101-001: 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 | Terminated | Sponsor: Kyverna Therapeutics | Trial completion date: Aug 2027 ➔ May 2026 | Active, not recruiting ➔ Terminated; Study discontinued due to sponsor decision.

Trial completion date • Trial termination • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

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 | Terminated | Sponsor: Kyverna Therapeutics | Trial completion date: Mar 2027 ➔ Jun 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Mar 2026 ➔ Jun 2026; Study discontinued due to sponsor decision

Trial completion date • Trial primary completion date • Trial termination • Immunology • Scleroderma • Systemic Sclerosis

CD19 CAR T cell therapy for treatment-refractory seropositive rheumatoid arthritis: a phase 1 trial. (PubMed, Nat Med) - P1/2 | "Here we report clinical and molecular data obtained during the nonrandomized phase 1 part of the phase 1/2 COMPARE trial, evaluating safety and efficacy of mivocabtagene autoleucel (miv-cel), an autologous fully human CD19 CAR T cell therapy, in rheumatoid arthritis (RA)...CD19 CAR T cells showed acceptable short-term tolerability in patients with treatment-refractory RA, justifying further evaluation. ClinicalTrials.gov identifier: NCT06475495 ."

Journal • P1 data • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • VIM

Miv-cel Earns RMAT Designation for Progressive Multiple Sclerosis (CGTLive) - "The designation, granted in August 2026, was based on what the company described as compelling clinical data from an ongoing Stanford University investigator-initiated trial (IIT)...The company said it will report additional Stanford IIT data in the fourth quarter of 2026."

FDA event • P1 data • Immunology • Multiple Sclerosis

Mivocabtagene autoleucel: Additional data from P1 trial (NCT06138132) for progressive multiple sclerosis in H2 2026 (Kyverna) - Corporate Presentation

P1 data • Immunology • Multiple Sclerosis

Mivocabtagene autoleucel: Follow-up data from P2 part of P2/3 KYSA-6 trial (NCT06193889) for myasthenia gravis in Q3 2026 (Kyverna) - Corporate Presentation: Enrollment completion of P3 part of P2/3 KYSA-6 trial for myasthenia gravis in mid-2027

Enrollment status • P2 data • Immunology • Myasthenia Gravis

KYSA-4: A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101 (clinicaltrials.gov) - P2/3 | N=70 | Recruiting | Sponsor: Kyverna Therapeutics | Phase classification: P ➔ P2/3

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

Kyverna Therapeutics…and ElevateBio…announced a manufacturing agreement for both U.S. commercial and global clinical supply of miv-cel (mivocabtagene autoleucel), Kyverna’s autologous CD19-directed CAR T-cell therapy (GlobeNewswire) - "The new agreement provides Kyverna with flexible and scalable supply of miv-cel, supporting the Company’s potential launches in stiff person syndrome (SPS) and generalized myasthenia gravis (gMG), as well as other ongoing clinical studies....Kyverna remains on track to complete the rolling BLA submission for miv-cel in SPS in the fourth quarter of 2026."

FDA filing • Licensing / partnership • CNS Disorders • Immunology • Myasthenia Gravis

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 | Trial primary completion date: Apr 2026 ➔ Jul 2026

Trial primary completion date • CNS Disorders • Immunology

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=27 | Completed | Sponsor: Kyverna Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Jun 2026

Trial completion • Trial completion date • CNS Disorders • Immunology

Long-Term Remission with Anti-CD19 CAR-T Cell Therapy in Refractory Myasthenia Gravis: A Two-Year Case Series (ICNMD 2026) - "Anti-CD19 chimeric antigen receptor (CAR) T cell therapy has recently emerged as a promising strategy to eliminate autoreactive B cells in autoimmune diseases. We describe the first two cases of severe, treatment-refractory, acetylcholine receptor antibody–positive MG, including one patient with concomitant rheumatoid arthritis, treated with a single infusion of anti-CD19 CAR T cells (KYV-101) following lymphodepleting chemotherapy... Anti-CD19 CAR T cell therapy induced durable clinical remission in patients with refractory MG and demonstrated an acceptable safety profile, even in the presence of persistent autoantibody levels. These findings highlight the potential of CAR T cell therapy as a transformative treatment for severe autoimmune neuromuscular disorders and support further evaluation in larger clinical studies."

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

Clinical Outcomes with exploratory biomarker analyses from phase 2 of KYSA-6, an open-label, single arm, multicenter study of miv-cel in gMG (EAN 2026) - P2/3 | "With a single dose, miv-cel induced deep B-cell depletion with evidence of immune reset. Patients experienced rapid, robust, and sustained improvements in disease severity with acceptable safety. Miv-cel demonstrates the potential to deliver durable, drug-free, disease-free remission in patients with gMG."

Biomarker • Clinical • Clinical data • P2 data • CNS Disorders • Immunology • Myasthenia Gravis • LRP4

Kyverna Therapeutics Highlights Updated Miv-cel Data at EULAR Demonstrating Substantial Reduction in Disease Activity in ACPA-Positive, Treatment Refractory Rheumatoid Arthritis (GlobeNewswire) - "Deep depletion of autoreactive CD19+ B cells and plasmablasts in periphery and tissues; Rapid and substantial reduction in disease-associated autoantibodies, including ACPA, rheumatoid factor immunoglobulin A (IgA) and M (IgM), for up to 52 weeks, while preserving long-term protective vaccine immunity; Substantial reduction in disease activity in all six patients who showed fewer tender and swollen joints and less joint inflammation following a single dose of miv-cel. In addition, the majority of patients (66.6%) met the ACR70 response by Week 36; Evidence of immune reset with repopulated B-cells returning as predominantly naïve and transitional cells; Well-tolerated safety profile with no high-grade cytokine release syndrome (CRS) and no immune effector cell-associated neurotoxicity syndrome (ICANS)....Based on the Phase 1 findings, the Phase 2 portion of the COMPARE trial has been initiated and is fully enrolled."

P1 data • Trial status • Immunology • Rheumatoid Arthritis

Long-term safety and efficacy of anti-CD19 CAR T-cell therapy with mivocabtagene autoleucel in ANCA-associated vasculitis (EULAR 2026) - "Background Rituximab-mediated B-cell depletion is a cornerstone of the therapeutic management for cytoplasmic antibody (ANCA)-associated vasculitis...Given the refractory disease course, anti-CD19 CAR T-cell therapy with mivocabtagene autoleucel (miv-cel), an autologous, fully human CD19-directed CAR T-cell therapy was initiated following standard lymphodepletion with fludarabine and cyclophosphamide, as previously described (3,4)...At the latest follow-up, Patient 1 had mildly elevated PR3 levels (30.5 AU/mL; upper limit of normal <20 AU/mL), while Patient 2 remained seronegative. Conclusions These findings provide initial evidence supporting the long-term safety and efficacy of anti-CD19 CAR T-cell therapy with miv-cel in patients with refractory ANCA-associated vasculitis, warranting further evaluation in prospective, controlled clinical trials."

CAR T-Cell Therapy • Clinical • ANCA Vasculitis • Hematological Disorders • Infectious Disease • Inflammation • Leukopenia • Pneumonia • Rare Diseases • Respiratory Diseases • Vasculitis

Baseline B-cell counts and inflammation markers predicting likelihood and severity of toxicity to CAR T-cell therapy in patients with autoimmune disease (EULAR 2026) - P=N/A, P1, P1/2 | "Most of the patients received lymphodepletion (LD) with cyclophosphamide and fludarabine prior CAR-treatment, one patient received bendamustine...78 (72%) patients received CD19-targeting (zorpocabtagene autoleucel (MB-CART19.1), mivocabtagene autoleucel (KYV-101), or BMS-986353) and 30 (28%) patients received CD19- and BMCA-targeting (co-infusion or dual-targeting CAR-T) therapy...Baseline B-cell counts and interleukin-6 may represent predictive biomarkers for CRS in AID patients treated with CAR T-cells. Strategies for B-cell depletion and better control of systemic inflammation prior to CAR T-cell therapy could improve the tolerability of CAR T-cell therapy."

CAR T-Cell Therapy • Clinical • IO biomarker • Hematological Malignancies • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • CRP • IL6

Emerging Efficacy and Safety of Mivocabtagene Autoleucel, a Fully Human CD19 CAR T-Cell Therapy, in Severe Autoimmune Rheumatic Diseases (EULAR 2026) - "Low-grade cytokine release syndrome occurred in all patients (grade 1: n=4; grade 2: n=3) and responded promptly to tocilizumab, with adjunctive dexamethasone in four cases, no intensive care support was required. Conclusions Autologous fully human CD19 CAR T-cell therapy with miv-cel induced sustained, immunosuppression-free clinical responses and had a favorable safety profile in patients with severe, refractory autoimmune rheumatic diseases. These findings support further prospective studies to define long-term efficacy and safety of fully human CD19 CAR T-cell constructs in autoimmune diseases."

CAR T-Cell Therapy • Clinical • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Myositis • Neutropenia • Rare Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

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) - "Deep phenotyping is ongoing to assess the depth of total and ACPA-expressing B-cell depletion within synovial and bone marrow compartments. Conclusions CD19 CAR T-cell therapy with miv-cel induces profound depletion of total B cells and reshapes early B-cell reconstitution toward a naive phenotype in ACPA-positive RA, supporting the concept of immune reset."

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

CD19 CAR T-Cell Therapy in ACPA-Positive, Treatment-Refractory, Active Rheumatoid Arthritis - Data from the Phase 1 of the Prospective, Interventional COMPARE Trial (EULAR 2026) - "All patients received a single infusion of miv-cel, following fludarabine-cyclophosphamide lymphodepletion...Patients had high baseline disease activity (median DAS28-CRP 5.5, range 4.1–6.2) and extensive prior treatment exposure (median 6.5 b/tsDMARDs, range 3–8), including rituximab in four patients (Tab...Conclusions In this first prospective evaluation of CD19 CAR T-cell therapy in ACPA-positive, treatment-refractory, active RA, miv-cel demonstrated a favourable safety profile and strong signals of clinical and serological efficacy. The depth of B-cell depletion, reduction of pathogenic autoantibodies, and early immunosuppression-free remission signals support the concept of an immunological reset in a significant proportion of patients."

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

Kyverna Therapeutics has officially started a rolling Biologics License Application submission to the FDA for miv-cel, keeping the candidate on track to be the first autoimmune CAR-T to reach the market. (FierceBiotech) - "The filing comes after the agency agreed with the company’s plan during a recent meeting, confirming that data from the single-arm KYSA-8 trial will be sufficient to support an application in stiff person syndrome, Kyverna said Tuesday alongside its first-quarter earnings report. Kyverna is seeking priority review under its Regenerative Medicine Advanced Therapy (RMAT) designation and anticipates completing the filing by the fourth quarter of 2026....Besides, while the agency has agreed on KYSA-8's primary endpoint based on a timed 25-foot walk test (T25FW) at 16 weeks, Kyverna will also submit data from a one-year follow-up, which is expected in the second half of 2026."

FDA filing • CNS Disorders • Rare Diseases

Multimodal Phenotyping of B Cell Depletion and Reconstitution Following Miv-cel CD19 CAR T Cell Therapy (EWRR 2026) - "Purpose Rheumatoid arthritis (RA) is a chronic inflammatory disease that is driven by a dysregulated B cell response. Conclusion Miv-cell CD19 CAR T cell therapy induces profound depletion of total B cells and reshapes early B cell reconstitution toward a naive state. During Phase I we established a scalable workflow for detailed characterization of B cells, which will be applied in Phase II to directly compare Miv-cell with rituximab and determine whether CAR T cell therapy provides superior and more durable control of autoreactive B cell responses in RA."

CAR T-Cell Therapy • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis