Actively Recruiting
Phase 2 Study of Emapalumab to Prevent Toxicities from Axicabtagene Ciloleucel Treatment in Adults with Large B-cell Non-Hodgkins Lymphoma
Led by Marcela V. Maus, M.D.,Ph.D. · Updated on 2025-11-14
28
Participants Needed
2
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
This research evaluates emapalumab as a preventive treatment for toxic side effects related to axicabtagene ciloleucel therapy in adults with certain types of large B-cell non-Hodgkins lymphoma that have returned or not responded to previous treatments. This phase 2 study focuses on the safety and effectiveness of emapalumab alongside approved therapies to better manage these treatment-related complications. Participants receive several treatments in sequence first, their T cells are collected through leukapheresis. Then, they undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine for three days. On the day before receiving axicabtagene ciloleucel, participants get a single intravenous dose of emapalumab. Axicabtagene ciloleucel is administered once by infusion on the following day. After completing these treatments, participants are monitored for up to 24 months. Throughout the study, participants will undergo assessments to track the incidence of cytokine release syndrome CRS and other neurological side effects, as well as the lymphomas response to treatment. Regular follow-up visits include evaluations of safety and effectiveness, with detailed monitoring of blood tests, physical health, and symptoms. The total participation time covers treatment and two years of follow-up to gather comprehensive outcome data.
CONDITIONS
Brief Title
Emapalumab Prevention of CAR-T Cell Associated Toxicities
Research Team
M
Matthew Frigault, MD
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