eligibility_summary
Adults (≥18) at Bern Inselspital planned for commercial CAR-T (lymphoma, leukemia, myeloma), with consent and deemed clinically fit. Exclude: prior tocilizumab within 3 months, investigational drug within 8 weeks, pregnant/breastfeeding or inadequate contraception (females of childbearing potential, required during study +12 months), inability to comply, prior enrollment, investigator or dependent persons.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
PRONTO (NCT06430736) compares prophylactic vs on-demand tocilizumab in adults receiving CD19 CAR-T for B‑cell malignancies (lymphoma, leukemia, myeloma). Tocilizumab (Actemra) is a humanized IgG1 monoclonal antibody that binds IL‑6 receptor (soluble and membrane-bound), blocking IL‑6–GP130 signaling (classic and trans) and downstream JAK/STAT3 inflammatory cascades. Goal: reduce cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity (ICANS). Arms: (1) prophylactic single 8 mg/kg IV dose 1 h before CAR‑T, (2) standard on-demand 8 mg/kg IV at first CRS signs, repeatable every 8 h (up to 4). Targeted cells/pathways: IL‑6/IL‑6R pathway on immune and endothelial cells driving hyperinflammation, indirectly tempers cytokine production from myeloid cells and limits overactivation of infused CAR‑T cells. CAR‑T targets CD19+ B cells.