What are adverse effects of chimeric antigen receptor (CAR) T-cell therapy and how are they managed?

Updated: Dec 17, 2020
  • Author: Sameh Gaballa, MD, MS; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

Answer

CAR T cell therapy has a unique set of acute toxicities that include cytokine release syndrome (CRS), neurologic toxicity, cytopenias, and B-cell aplasia. These adverse events can be fatal and require special management. For this reason, the FDA mandates inclusion of a risk evaluation and mitigation strategy (REMS) that requires special certification for hospitals and clinics as well as additional training for physicians and support staff. [11]

Patients often require hospitalization to receive CAR T therapy, although this depends on the CAR T product, the bulk of the disease, and the proximity of the patient to the CAR T center. Patients receiving CAR T constructs with accelerated expansion kinetics (eg, CD28-based constructs) often require hospitalization for at least 7 days after the CAR T infusion.

Reporting and grading of toxicities is challenging. Comparison across clinical trials is difficult, as different grading criteria were often used. However, in 2019 the American Society for Transplantation and Cellular Therapy (ASTCT) published a consensus grading system to simplify the grading and reporting of CRS and neurologic toxicities (immune effector cell–mediated neurotoxicity syndrome [ICANS]). The ASTCT scoring system is easy to calculate clinically at the bedside, and is gaining rapid adoption in clinical practice. [33]  

Other challenges of CAR T cell therapy include its extremely high cost and the need for complicated logistical planning. This restricts the administration of this therapy to large tertiary referral centers, which can limit the ability of patients to receive it.


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