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A Guide for Initiating and Managing Chimeric Antigen Receptor T Cell Therapy Clinical Trials in Autoimmune Rheumatic

Roberto Caricchio1, Stacie Bell2, Sasha Bernatsky3

  • 1Lupus Center, University of Massachusetts Chan Medical School, Worcester.

ACR Open Rheumatology
|November 28, 2025
PubMed
Summary

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Chimeric antigen receptor (CAR) T-cell therapy shows promise for autoimmune diseases like lupus by depleting B-cells and inducing remission. However, its widespread use requires overcoming significant logistical, regulatory, and clinical challenges for safe and effective implementation.

Area of Science:

  • Immunology
  • Rheumatology
  • Cellular Therapy

Background:

  • Chimeric antigen receptor (CAR) T-cell therapy has transformed oncology.
  • Emerging evidence suggests CAR T-cell therapy's potential in autoimmune rheumatic diseases, including systemic lupus erythematosus (SLE).
  • Early studies indicate deep B-cell depletion, immune resetting, and durable drug-free remission in SLE patients.

Purpose of the Study:

  • To outline the complexities and requirements for translating CAR T-cell therapy into rheumatology clinical practice.
  • To identify critical factors for the safe and rigorous execution of CAR T-cell clinical trials in autoimmune diseases.

Main Methods:

  • This review synthesizes current evidence and expert considerations for CAR T-cell therapy implementation in rheumatology.

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  • It addresses logistical, regulatory, clinical, and ethical challenges, including institutional readiness, multidisciplinary team formation, and patient management.
  • It also highlights operational bottlenecks, financial planning, and the need for long-term follow-up and patient engagement.

    • Main Results:

    • Successful translation necessitates robust institutional infrastructure, including specialized teams and operational workflows.
    • Management of toxicities (CRS, ICANS, ICAHT, LICATS) and autoimmune-specific reactions is crucial.
    • Addressing challenges like apheresis access, manufacturing capacity, and patient heterogeneity is essential for trial success.

    Conclusions:

    • Implementing CAR T-cell therapy in rheumatology requires a multidisciplinary approach and meticulous planning.
    • Overcoming operational, financial, and ethical hurdles is vital for maximizing therapeutic potential.
    • Collaboration among healthcare providers, industry, and patient organizations is key to advancing CAR T-cell therapy for autoimmune diseases.