Pilot, Open-Label Study of Tadekinig Alfa IL-18BP Rescue Therapy for CAR T Cell Related Cytokine Release Syndrome and HLH-like Syndrome

What this Trial Is About

Researchers are conducting a pilot, open-label study to assess the safety and feasibility of using investigational drugs as rescue therapies for cytokine release syndrome CRS and HLH-like syndrome CRHLS related to CAR T cell therapy. The study allows co-enrollment of participants already receiving CAR T cell treatments under University of Pennsylvania-sponsored trials. The investigational drug studied, Tadekinig alfa, targets IL-18, a key factor in inflammatory conditions that may worsen CRS and CRHLS. Participants may receive Tadekinig alfa as a rescue treatment if clinically necessary after CAR T cell infusion. The drug is given by subcutaneous injection starting with a loading dose on Day 1, followed by repeat injections on Days 3 and 5, approximately 48 hours apart. Continued dosing every 48 to 72 hours and retreatment may be considered based on symptoms and clinical response. During the study, participants will be monitored for safety and how well the investigational drug can be administered as rescue therapy over a 28-day period. Researchers will assess the preliminary safety and feasibility of this treatment. Participants will be evaluated through regular clinical assessments and dosing schedules, with no masking or placebo control involved.

Tadekinig Alfa (IL-18BP) Rescue Therapy for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome