KYV-101 / Kyverna 
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  • ||||||||||  KYV-101 / Kyverna
    A Study of Kyv-101, a CD19 CAR T Cell Therapy, in Participants with Treatment Refractory Progressive Multiple Sclerosis (Halls G-H (San Diego Convention Center)) -  Nov 21, 2024 - Abstract #ASH2024ASH_7148;    
    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
  • ||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma, Kineret (anakinra) / SOBI, KYV-101 / Kyverna
    CD19-Directed CAR T Cell Therapy in 4 Patients with Refractory Multiple Sclerosis (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3796;    
    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.
  • ||||||||||  KYV-101 / Kyverna
    Journal, CAR T-Cell Therapy:  Successful use of anti-CD19 CAR T cells in severe treatment-refractory stiff-person syndrome. (Pubmed Central) -  Jun 17, 2024   
    KYV-101 CAR T cells were well tolerated with only low-grade cytokine release syndrome. This report of successful use of anti-CD19 CAR T cells in treatment-refractory SPS supports continued exploration of this approach in SPS and other B cell-related autoimmune disorders.
  • ||||||||||  KYV-101 / Kyverna
    Phase classification, Enrollment change, CAR T-Cell Therapy:  KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (clinicaltrials.gov) -  Apr 17, 2024   
    P1/2,  N=32, Recruiting, 
    Hu19-CD828Z CAR T cells generated from SLE patient lymphocytes demonstrate CAR-mediated and CD19-dependent activity against autologous primary B cells with reduced inflammatory cytokine production supporting KYV-101 as a novel potential therapy for the depletion of pathogenic B cells in SLE patients. Phase classification: P1 --> P1/2 | N=12 --> 32
  • ||||||||||  KYV-101 / Kyverna
    Trial completion date, Trial initiation date, Trial primary completion date, CAR T-Cell Therapy:  CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 (clinicaltrials.gov) -  Apr 4, 2024   
    P1,  N=24, Not yet recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Feb 2028 --> Jun 2028 | Initiation date: Feb 2024 --> Jun 2024 | Trial primary completion date: Feb 2028 --> Jun 2028
  • ||||||||||  KYV-101 / Kyverna
    Journal, CAR T-Cell Therapy:  CD19-targeted chimeric antigen receptor T cell therapy in two patients with multiple sclerosis. (Pubmed Central) -  Mar 30, 2024   
    CAR-T cell presence and expansion were observed in the cerebrospinal fluid without clinical signs of neurotoxicity, which, along with intrathecal antibody reduction, indicates expansion-dependent effects of CAR-T cells on CD19+ target cells in the CNS. Larger clinical studies assessing CD19 CAR-T cells in MS are warranted.
  • ||||||||||  KYV-101 / Kyverna
    Anti-CD19 CAR T-Cell Therapy in Rheumatologic Autoimmune Diseases and Beyond (Strauss 3) -  Mar 29, 2024 - Abstract #EULAR2024EULAR_1071;    
    The audience will gain an understanding of the potential of investigational CAR T-cell therapies, including KYV-101, an investigational anti-CD19 CAR T-cell therapy, in rheumatology and beyond. A multidisciplinary expert panel discussion will further comment on the advances in CAR T-cell therapies, addressing questions from the audience.
  • ||||||||||  KYV-201 / Kyverna, Intellia Therap
    PRECLINICAL DEVELOPMENT OF KYV-201, AN INVESTIGATIONAL ALLOGENEIC ANTI-CD19 CAR T CELL FOR THE TREATMENT OF AUTOIMMUNE DISEASE (Poster View) -  Mar 29, 2024 - Abstract #EULAR2024EULAR_744;    
    KYV-201 combines the same fully human anti-CD19 CAR construct as KYV-101, an autologous CAR T-cell therapy being studied in lupus nephritis, systemic sclerosis, myasthenia gravis, and multiple sclerosis, with a differentiated allogeneic platform developed by Intellia Therapeutics involving selected CRISPR/Cas9-mediated gene edits[2,5]. The preclinical data generated for KYV-201 demonstrates the functionality and safety necessary to advance to first-in-human studies, bringing the promise of allogeneic CD19 CAR T cells for autoimmune diseases closer to fruition.
  • ||||||||||  KYV-101 / Kyverna
    FULLY HUMAN CD19-TARGETED CAR T CELLS IN A CASE OF REFRACTORY ANTI-ACHR ANTIBODY POSITIVE MYASTHENIA GRAVIS (CARRON) -  Feb 14, 2024 - Abstract #EBMT2024EBMT_1572;    
    Following lymphodepletion with fludarabine and cyclophosphamide, the patient received a single infusion of 1x108 anti-CD19 CAR T cells (day 0)... Our case report may serve as a foundation for conducting clinical trials with CD19 CAR T cells in MG and/or other neuroimmunological disorders and we plan to present a 1-year data update.
  • ||||||||||  KYV-101 / Kyverna
    Development of KYV-101, a Novel CD19 CAR-T Cell Therapy for the Treatment of B Cell-Driven Autoimmune Diseases (Board No. 636) -  Apr 6, 2023 - Abstract #ASGCT2023ASGCT_575;    
    KYV-101 generated from HDs and autoimmune disease patient lymphocytes demonstrates high affinity and specificity to human CD19 as well as CAR-mediated and CD19-dependent activity in vitro and in vivo against CD19+ cell lines and/or autologous, patient-derived primary B cells. KYV-101 thus represents a novel therapeutic option for the depletion of pathogenic B cells in autoimmune patients.