Outcomes Reporting

Chimeric antigen receptor (CAR) T cell therapies and other new immune effector cell therapies are offering hope for many patients with relapsed and refractory leukemia, lymphoma and other blood cancers. However, these therapies also have known serious side effects, including cytokine release syndrome (CRS) and immune effector cell neurotoxicity syndrome (ICANS). Because the definitions and grading of these toxicities have varied, safety comparisons, toxicity measurement and development of strategies to manage the toxicities have been difficult. A proposed standardized approach to define and grade CRS and ICANS aims to change that. On Jan. 30, the American Society for Transplantation and Cellular Therapy (ASTCT), formerly the ASBMT, released a paper that proposes a new consensus grading scale for CRS and ICANS to be applied across clinical trials, academic research and commercial product development. According to an ASTCT news release, the grading scale was developed by stakeholders from multiple major CAR T centers, commercial product industry representatives, the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the American Society of Hematology, the National Cancer Institute and others. Stakeholders participated in three ASTCT-supported meetings in the summer and fall of 2018 that resulted in “new definitions and grading for CRS and neurotoxicity that are objective, easy to use, and ultimately more accurately categorize the severity of these toxicities.” “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,” said Stephan Grupp, M.D., Ph.D., section chief of the Children’s Hospital of Philadelphia’s Cell Therapy and Transplant Section, and one of the authors of the paper. The open-access paper title, titled, “ASTCT Consensus Grading for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells,” also recommends use of the CIBMTR Cellular Therapy Registry to meet the outcomes data reporting requirements for current and future cell therapies. According to the paper, “Using a single, standardized database to capture information about recipients of immune effector cell therapies can streamline the process and can provide a resource for research. The CIBMTR's Cellular Therapy Registry infrastructure is well suited to meet this requirement.” The paper went on to state, “The CIBMTR built the Cellular Therapy Registry to serve the community and to help advance the field by making the data available to investigators. Standardized collection of toxicity data in the real-world setting will help identify ways to make these therapies safer.” “We thank the ASTCT leaders for their work to bring together stakeholders from throughout the industry to develop this consensus grading system,” said Steven Devine, M.D., medical director, Be The Match BioTherapies®, and senior vice president of Research and associate scientific director, CIBMTR, who contributed to the development of the consensus document. “By implementing a standardized grading system and reporting database, we can advance new cellular therapies and create safer therapies for patients sooner.” Learn about our outcomes data collection and analysis capabilities. Related story: As CAR-T therapies mature, researchers begin to track long-term patient outcomes

Outcomes Reporting

Industry stakeholders propose unified CAR T toxicity grading scale

As CAR-T therapies mature, researchers begin to track long-term patient outcomes