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J Hematol Oncol. 2018 Mar 2;11(1):35. doi: 10.1186/s13045-018-0571-y.

Grading of cytokine release syndrome associated with the CAR T cell therapy tisagenlecleucel.

Author information

1
Division of Hematology-Oncology, Blood and Marrow Transplantation and Cellular Therapy Program, Perelman School of Medicine and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA. David.Porter@uphs.upenn.edu.
2
Division of Hematology-Oncology, Blood and Marrow Transplantation and Cellular Therapy Program, Perelman School of Medicine and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
3
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
4
Department of Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, USA.
5
Division of Oncology, Center for Childhood Cancer Research and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, 3501 Civic Center Blvd. CTRB 3006, Philadelphia, PA, 19104, USA.

Abstract

BACKGROUND:

Anti-CD19 CAR T cell therapy has demonstrated high response rates in patients with relapsed or refractory (r/r) B cell malignancies but is associated with significant toxicity. Cytokine release syndrome (CRS) is the most significant complication associated with CAR T cell therapy, and it is critical to have a reproducible and easy method to grade CRS after CAR T cell infusions.

DISCUSSION:

The Common Terminology Criteria for Adverse Events scale is inadequate for grading CRS associated with cellular therapy. Clinical experience with the anti-CD19 CAR T cell therapy tisagenlecleucel at the University of Pennsylvania (Penn) was used to develop the Penn grading scale for CRS. The Penn grading scale depends on easily accessible clinical features; does not rely on location of care or quantitation of supportive care; assigns grades to guide CRS management; distinguishes between mild, moderate, severe, and life-threatening CRS; and applies to both early-onset and delayed-onset CRS associated with T cell therapies. Clinical data from 55 pediatric patients with r/r B cell acute lymphoblastic leukemia and 42 patients with r/r chronic lymphocytic lymphoma treated with tisagenlecleucel were used to demonstrate the current application of the Penn grading scale.

CONCLUSION:

We show that the Penn grading scale provides reproducible CRS grading that can be useful to guide therapy and that can be applied across clinical trials and treatment platforms.

KEYWORDS:

CAR T cell therapy; Cytokine release syndrome; Safety

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