"My T Cell": A Smartphone Application for Guidance of CAR T Logistics and Management of CAR T & BiTE Related Toxicities

The Bispecific T-cell engager (BiTE) Blinatumomab and CD19-specific Chimeric Antigen Receptor (CAR) T-cell products are approved for the treatment of relapsed and refractory B-cell neoplasms. However, these T-cell based immunotherapies can be accompanied by immune-related toxicities differing from adverse events of classical cytotoxic agents. Toxicity management can pose a challenge for health care professionals. Additionally, logistics of CAR T-cell patient management, particularly with regard to timelines of apheresis, bridging therapies, and CAR T-cell transfusion, require coordinated efforts between referring physicians and treatment centers. To support the optimal management of these patients, we developed an interactive smartphone application ("myTcell") which educates physicians in the pre-treatment logistics of CARs and BiTEs and provides recommendations on management and treatment of immune-related toxicities.

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 integrated in an information platform to provide diagnostic and therapeutic recommendations as well as algorithms for interactive toxicity grading tools. We could successfully implement an app ("myTcell") guiding health workers in a disease- and product-specific step by step process through the clinical workflow of CAR and BiTE therapy (Fig.1). This includes recommendations for eligibility, 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 and grade-specific management (Fig. 2). Further, "myTcell" assists with the diagnosis and treatment of pancytopenia and infections. The app includes an overview of important publications with direct links to respective abstracts to support evidence-based decision-making. A prototype was validated at five Geman treatment centers through a questionnaire which measured the advantage of the app compared to common clinical practice.

38 physicians with a median working experience of 8 years validated the app protoype in a real-world setting of CAR T-cells or BiTE application for the treatment of Diffuse Large-B-Cell Lymphoma (89.5%) and B-Cell Precursor Acute Lymphoblastic Leukemia (39.5%) at five German treatment centers (University Hospitals of LMU Munich, Cologne, Göttingen, Erlangen, Tübingen). 78.9% of the users most valued the content of toxicity management. In addition, 63.2% reported to dominantly use the interactive tools and calculators to assess severity of toxicities and to instantly receive grade-specific management recommendations. As expected, the tools were most frequently used for the two most commonly occurring side effects CRS (68.4%) and ICANS (65.8%). In addition, most of the users agreed, that the interactive tools improved toxicity management (94.7%) and saved time during their clinical practice (81.6%). Based on these results, "myTcell" has been certified as a medicinal product class I and has been released in the app stores and for desktop application (www.mytcell.de) on July 15, 2021.

"myTcell" is a smartphone app supporting the use of T-cell based immunotherapy platforms. The app supports assessment and treatment of novel CAR T and BITE mediated immunotoxicities. Health care professionals validated feasibility and in particular appreciated fast and easy assessment of toxicity grading and management. Thus, "myTcell" is a tool that has the potential to improve guideline adherence and accelerate broader and safer application of CARs and BiTEs based immunotherapy.

Figure 1

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Figure 1

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