{
  "abstract": "Early data have shown the potential of chimeric antigen receptor (CAR) T-cell therapies to expand the therapeutic landscape in systemic lupus erythematosus (SLE). While many CAR T-cell therapy learnings can be drawn from the experience of this modality in oncology, key questions remain regarding clinical development considerations unique to lupus. To assess and discuss these issues, the Lupus Accelerating Breakthroughs Consortium, a public–private partnership, convened a multi-partner working group to collect the diverse perspectives of academics/clinicians (including rheumatologists and oncologists), industry representatives (including SLE as well as CAR T-cell clinical development experts), regulators and people living with lupus on this potentially ground-breaking therapy. The working group considered the risk/benefit considerations for eligibility criteria in lupus, early-phase dosing and dose-limiting toxicity challenges, incorporation of comparator arms in late-phase registrational trial design, SLE-specific issues in conditioning therapy and immune monitoring and the limitations of SLE pre-clinical models for studying cell therapies. The key future ‘calls to action’ for the field include the need for well-defined severity/refractoriness-based eligibility criteria, the need for long-term monitoring infrastructure and the need for educational and logistical support for rheumatologists and patients.",
  "authors": [
    {
      "affiliations": [
        "Department of Immunology and Microbiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA"
      ],
      "name": "Elena W Y Hsieh"
    },
    {
      "affiliations": [
        "Amgen Inc, Thousand Oaks, California, USA"
      ],
      "name": "James B Chung"
    },
    {
      "affiliations": [
        "Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"
      ],
      "name": "Afsah Amin"
    },
    {
      "affiliations": [
        "Columbia University Irving Medical Center, New York, New York, USA"
      ],
      "name": "Anca D Askanase"
    },
    {
      "affiliations": [
        "Gilead Sciences Inc, Foster City, California, USA"
      ],
      "name": "Beatrix Bartok"
    },
    {
      "affiliations": [
        "Sana Biotechnology Inc, Seattle, Washington, USA"
      ],
      "name": "Paul Brunetta"
    },
    {
      "affiliations": [
        "AstraZeneca, Boston, Massachusetts, USA"
      ],
      "name": "Marlene J Carrasco-Alfonso"
    },
    {
      "affiliations": [
        "Lupus Voices Council, Lupus Research Alliance, New York, New York, USA"
      ],
      "name": "Cindy Coney"
    },
    {
      "affiliations": [
        "Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA"
      ],
      "name": "Jennifer C Cooper"
    },
    {
      "affiliations": [
        "University of California San Francisco, San Francisco, California, USA"
      ],
      "name": "Maria Dall’Era"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb Co, Princeton, New Jersey, USA"
      ],
      "name": "Nikolay Delev"
    },
    {
      "affiliations": [
        "AbbVie Inc, North Chicago, Illinois, USA"
      ],
      "name": "Ann Eldred"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Northwell Health, Great Neck, New York, USA"
      ],
      "name": "Richard A Furie"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb Co, Princeton, New Jersey, USA"
      ],
      "name": "Sandra Garces"
    },
    {
      "affiliations": [
        "Michigan Lupus Foundation, Traverse City, Michigan, USA"
      ],
      "name": "Katie Groover"
    },
    {
      "affiliations": [
        "Fluent in Science, LLC, New York, New York, USA"
      ],
      "name": "Monica Harrington"
    },
    {
      "affiliations": [
        "Cabaletta Bio Inc, Philadelphia, Pennsylvania, USA"
      ],
      "name": "Jonathan J Hogan"
    },
    {
      "affiliations": [
        "Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"
      ],
      "name": "Gavin H Imperato"
    },
    {
      "affiliations": [
        "Lupus Research Alliance, New York, New York, USA"
      ],
      "name": "Meredith Jackson"
    },
    {
      "affiliations": [
        "Center for Immunity and Immunotherapies, Seattle Children’s Research Institute, Seattle, Washington, USA"
      ],
      "name": "Shaun W Jackson"
    },
    {
      "affiliations": [
        "GlaxoSmithKline, Philadelphia, Pennsylvania, USA"
      ],
      "name": "Artemio M Jongco"
    },
    {
      "affiliations": [
        "Nkarta Inc, South San Francisco, California, USA"
      ],
      "name": "Elaine Karis"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb Co, Princeton, New Jersey, USA"
      ],
      "name": "Ashley Koegel"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA",
        "Ludwig Center, Johns Hopkins Medicine Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA"
      ],
      "name": "Maximilian F König"
    },
    {
      "affiliations": [
        "Cornell University, Ithaca, New York, USA"
      ],
      "name": "Gary Koretzky"
    },
    {
      "affiliations": [
        "Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"
      ],
      "name": "Vijay Kumar"
    },
    {
      "affiliations": [
        "School of Clinical Sciences, Monash University, Clayton, Victoria, Australia",
        "Monash Health, Clayton, Victoria, Australia"
      ],
      "name": "Eric Morand"
    },
    {
      "affiliations": [
        "Columbia University Irving Medical Center, New York, New York, USA"
      ],
      "name": "Aimee S Payne"
    },
    {
      "affiliations": [
        "Center for Biologics Research and Evaluation, US Food and Drug Administration, Silver Spring, Maryland, USA"
      ],
      "name": "Vaishali Popat"
    },
    {
      "affiliations": [
        "Synthekine Inc, Menlo Park, California, USA"
      ],
      "name": "Naiyer Rizvi"
    },
    {
      "affiliations": [
        "Division of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA"
      ],
      "name": "Patricia Rohan"
    },
    {
      "affiliations": [
        "Columbia University Irving Medical Center, New York, New York, USA"
      ],
      "name": "Michel Sadelain"
    },
    {
      "affiliations": [
        "Department of Medicine 3-Rheumatology and Immunology and Deutshes Zentrum Immuntherapie, Friedrich-Alexander-Universitat Erlangen-Nurnberg, Erlangen, BY, Germany",
        "Universitatsklinikum Erlangen, Erlangen, BY, Germany"
      ],
      "name": "Georg Schett"
    },
    {
      "affiliations": [
        "Takeda Pharmaceuticals America Inc, Cambridge, Massachusetts, USA"
      ],
      "name": "Aman P Singh"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Amsterdam University Medical Center, Amsterdam, Netherlands"
      ],
      "name": "Ronald F van Vollenhoven"
    },
    {
      "affiliations": [
        "Fate Therapeutics Inc, San Diego, California, USA"
      ],
      "name": "Debra Zack"
    },
    {
      "affiliations": [],
      "name": "Lupus ABC CAR T Working Group"
    }
  ],
  "title": "Key considerations for advancing chimeric antigen receptor (CAR) T-cell therapy for systemic lupus erythematosus (SLE): a multi-partner/disciplinary working group perspective",
  "uid": "1cc8b2f7-3ee8-595b-be65-016a11e1ca06"
}