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

A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Bruce Cree | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Multiple Sclerosis

A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Bruce Cree

New P1 trial • CNS Disorders • Multiple Sclerosis

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 | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

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

CD19 CAR T-Cell Therapy in Highly Treatment-Refractory Rheumatoid Arthritis: Phase 1 Results from the COMPARE Trial (ACR Convergence 2026) - " 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... 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 immunosuppression-free remission in a subset of patients."

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) - "Low-grade cytokine release syndrome (CRS) developed in all patients (grade 1, n=4; grade 2, n=3) and resolved promptly with tocilizumab, supplemented by dexamethasone in four cases. Fully human autologous CD19 CAR T-cell therapy with miv-cel achieved sustained disease control in the absence of continued immunosuppression and was well tolerated in patients with severe, refractory autoimmune rheumatic diseases. These results highlight the potential of fully human CD19 CAR T-cell constructs as an immune-reset strategy and support their further investigation in prospective clinical trials."

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

Immune Profiling after treatment with an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy in Treatment-Refractory Progressive Multiple Sclerosis. (PubMed, medRxiv) - "Two adult participants with treatment-refractory progressive MS were treated with 0.33×10^8 autologous anti-CD19 CAR-T cells (mivocabtagene autoleucel, miv-cel) intravenously after a preconditioning regimen...Overall, these results support the continued investigation of CAR-T cell therapy in MS. Anti-CD19 CAR-T cell was safe in two progressive MS patients with CSF penetration, OCB/IgG index resolution, and improved inflammatory background."

Journal • CNS Disorders • Epstein-Barr Virus Infections • Inflammation • Multiple Sclerosis

MGFA Session 2026: Single CAR T-cell therapy dose eases gMG up to 1.5 years (Myasthenia Gravis News) - "A single dose of mivocabtagene autoleucel CAR T-cell therapy led to reductions in symptom severity in generalized myasthenia gravis; Those reductions were sustained for up to 1.5 years, according to findings from the Phase 2 part of a clinical trial; Most participants reached a state where their gMG symptoms have little to no impact on their daily lives...All seven participants remained free of the need for other MG immunotherapies after six months, with six of them (85.7%) remaining off immunosuppressants at their last follow-up...Miv-cel was generally well-tolerated and lowered levels of disease-causing antibodies without compromising the immune system’s ability to produce infection-fighting antibodies."

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

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

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

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