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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 17, 2022

Primary Completion Date

January 31, 2026

Study Completion Date

April 30, 2026

Conditions
CRS - Cytokine Release SyndromeHLH
Interventions
DRUG

Tadekinig alfa (IL-18BP)

"Tadekinig alfa will be administered via subcutaneous injection. The site of subcutaneous injection should be rotated to avoid injection site reactions; e.g. the outside of the thighs, arms, and the various quadrants of the anterior abdominal wall.~* Injection #1/Day 1:~ o Loading dose of 4 mg/kg; Maximum dose of 350 mg.~* Repeat Injection(s): 2 mg/kg/injection; Maximum dose of 160 mg/injection. Missed doses will not be made up.~ * Injection #2/Day 3: Approximately 48 hours (+/- 5 hours) after receipt of the 1st injection.~ * Injection #3/Day 5: Approximately 48 hours (+/- 5 hours) after receipt of the 2nd injection.~ * Continued Dosing (Optional): Approximately q48-72 hours; If the subject is responsive to initial therapy, but has ongoing symptoms of CRS/CRHLS."

Trial Locations (1)

19104

RECRUITING

University of Pennsylvania, Philadelphia

All Listed Sponsors
lead

University of Pennsylvania

OTHER