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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

ASBMT introduces a unified grading system to assess CAR-T toxicities

The American Society for Blood and Marrow Transplantation (ASBMT) has published an article that proposes a new consensus grading scale for toxicities associated with CAR-T cell therapy. Applying the unified grading system across clinical trials, academic studies, and commercial products, the experts believe, will help develop the best strategies to manage these toxicities.  

CAR-T cell therapy has produced astonishing re­sults in clinical trials recently, resulting in the approval of Kymriah (Novartis) and Yescarta (Kite/Gilead) for treating B-cell malignancies. It is being tested in several other trials for treating various cancers.

The common side effects, cytokine release syndrome (CRS) and neurotoxicities (Immune effector Cell Associated Neurotoxicity Syndrome, or ICANS) associated with the therapy pose a major challenge to advancing this field. One of the major hurdles in developing strategies to manage these toxicities is the lack of consensus in the assessment and grading of CRS and ICANS across clinical settings.   

To solve this problem and harmonize the toxicity grading, the ASBMT conducted three meetings in 2018, where experts from all areas of the field gathered to develop a single definition and grading system for CRS and neurotoxicity. Participants included stakeholders from multiple major CAR T centres, industry representatives, the Center for International Blood and Marrow Transplant Research, the American Society of Hematology, the National Cancer Institute, and others.

ASBMT is a professional society of more than 2,200 individuals from over 45 countries. The society is dedicated to advancing the science and clinical care for patients who require blood and marrow transplants for blood cancers and other deadly diseases.

The resulting article published in the Biology of Blood and Marrow Transplantation, the ASBMT has introduced “new definitions and grading for CRS and neurotoxicity that are objective, easy to use, and ultimately more accurately categorize the severity of these toxicities.”

Dr Stephan Grupp, Section Chief of the Children’s Hospital of Philadelphia’s Cell Therapy and Transplant Section, and one of the authors of the paper commented: “Without a unified grading system in CAR-T cell therapy, there have even been doctors at the same treatment center using different products in the same types of patients and reporting toxicities differently. This has resulted in inconsistent assessments that prevent full understanding of the toxicity burden and hinder advancement of these therapies. Having entered the era of commercially available CAR T therapy products, it is crucial that data are reported in the same way. With the release of this ASBMT report, I believe stakeholders will see the added value of implementing a consistent grading system.”

Source: ASBMT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells; DOI