Background Bispecific T-cell engagers (BiTE) and CD19-specific Chimeric Antigen Receptor (CAR) T-cell products are approved for relapsed and refractory B-cell neoplasms. However, rapid disease progression and the pre-treatment workflow during manufacturing challenges several specialities of health care professionals and involves a well educated team in the in-patient and out-patient setting. In addition, CARs and BiTEs are accompanied by a new spectrum of immune related toxicities. Currently, clinical trials investigate the safety of outpatient CAR T-cell administration, requiring high-level care during the early post-infusion period. To support the optimal management of these patients, we developed the interactive smartphone application ‘myTcell’, which guides and educates physicians in the pre-treatment logistics of CARs and BiTEs and management of related toxicities.
Materials and Methods We initiated a multi step content development process with an extensive literature research of toxicity guidelines consented by the ASTCT, SITC, NCCN and EBMT as well as of officially released drug information. Findings were translated into an information platform with diagnostic and therapeutic recommendations as well as algorithms for interactive toxicity grading tools. A prototype has been validated at five Geman treatment centers through a questionnaire, which measures the advantage over common guideline practice. ‘myTcell’ will become available as medicinal product class I for iOS, Android and desktop in Europe on 15th of July. App development has been funded through educational grants by Celgene, Gilead Sciences, Janssen and Novartis.
Results ‘myTcell’ guides disease and product specific in a step by step process through the clinical workflow of cell therapy. This includes recommendations for patient screening, safety assessment and stopping rules prior to leukapheresis and CAR T-cell transfusion. Upon entering relevant clinical data for grading of CRS, ICANS and HLH interactive tools display toxicity grade or likelihood of toxicity as well as grade-specific management. Further, ‘myTcell’ assists with the diagnosis and treatment of pancytopenia and infections. A map visualizes the availability of CAR T-cell therapy in Germany and links in-patient and out-patient care. Besides, ‘myTcell’ includes an overview of important publications and refers directly to respective PubMed abstracts.
Conclusions ‘myTcell’ has the potential to become a highly usable smartphone app supporting the application of T-cell recruiting immunotherapies as well as the assessment and treatment of novel immunotoxicities. In addition, it facilitates outreach and connects treatment centers and referrig physicians. Thus, ‘myTcell’ can translate into increased guideline adherence, accelerated broader and safer application of CARs and BiTEs and improved patient outcomes.
Disclosure Information V. Blumenberg: B. Research Grant (principal investigator, collaborator or consultant and pending grants as well as grants already received); Significant; Novartis, Gilead Sciences, Janssen, BMS/Celgene. L. Siegmund: None. L. Fröhlich: None. M. Bergwelt: None. V. Bücklein: None. M. Subklewe: None.
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