Early Detection of Complications During Immunotherapy for Haematological Malignancy - Description of Associated Vital Signs and Immune Responses

What this Trial Is About

Researchers are investigating how to better identify patients with hematologic cancers who may develop serious complications after immunotherapy treatments such as chimeric antigen receptor T-cell therapy (CART) or bispecific antibodies (BsAbs). The study aims to improve early detection of conditions like cytokine release syndrome (CRS), a common and potentially severe side effect of these treatments. By understanding physiological and immunological changes, the research hopes to enhance patient monitoring and care. The study combines three research projects: continuous wireless monitoring of vital signs using the WARD system, immune function testing through TruCulture and Duraclone, and clinical observation in a specialized phase one unit. WARD continuously tracks heart rate, respiratory rate, blood pressure, and oxygen saturation using wearable devices. The phase one unit allows safe administration and close monitoring during treatment. Immune profiling measures markers of inflammation to explore links with clinical complications. Participants will undergo continuous vital sign monitoring and immune testing during and up to 30 days after immunotherapy. Researchers will collect data including ECGs, blood pressure readings, oxygen saturation, and immune responses to develop risk models predicting severe complications. Alarms notify health personnel of abnormal vital signs for timely intervention. The primary outcome is occurrence of cytokine release syndrome within 30 days, with secondary outcomes including immune response and physiological changes. The study will last through at least July 2027.

Early Detection of Complications During Immunotherapy for Haematological Malignancy