eligibility_summary
Eligibility: adults (≥18) with hematologic malignancies (e.g., lymphoma) scheduled for CAR T-cell or bispecific antibody therapy. Exclude if pregnant, have a pacemaker, allergic to device materials, or deemed unable to comply by investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06377059 tests a diagnostic device, not a drug. Intervention: WARD wireless monitoring system with alarms—continuous single‑lead ECG (heart rate), thoracic impedance (respiratory rate), noninvasive oscillometric BP, and pulse oximetry (SpO2)—to detect early physiologic changes and trigger timely clinical action during immunotherapy for hematologic malignancies. Secondary research tools: TruCulture/Duraclone for ex vivo immune stimulation/phenotyping and plasma biomarkers (CRP, IL‑6, TNF‑α). Context therapies: CAR‑T cell therapy (autologous engineered T cells expressing chimeric antigen receptors, cell therapy) and T‑cell–engaging bispecific antibodies (biologic antibodies that crosslink tumor antigens with CD3 on T cells). Targets/pathways: T‑cell activation via CD3 signaling, tumor antigen recognition, cytokine release pathways driving CRS (IL‑6, TNF‑α), and physiologic correlates (fever, hypotension, hypoxia, tachycardia). Primary aim: risk-modeling for early complication detection.