RecruitingEarly Phase 1NCT05306080

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

Pilot, Open-Label Study Evaluating the Safety and Feasibility of Using Rescue Therapies for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome

Sponsor

University of Pennsylvania

Enrollment

10 participants

Start Date

Apr 17, 2022

Study Type

INTERVENTIONAL

Conditions

CRS - Cytokine Release Syndrome HLH

Summary

This is a pilot, open-label study to assess the safety and feasibility of using investigational drug(s) as rescue therapies for CAR T cell related CRS and HLH-like syndrome (CRHLS).

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Signed, written informed consent
Male or female patients age ≥ 18 years
Have been co-enrolled in a University of Pennsylvania-Sponsored, CCI-Initiated CAR T cell clinical trial.
Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol

Exclusion Criteria2

Pregnant or nursing (lactating) women.
Known hypersensitivity to the active substance or one of the excipients of the investigational product(s).

Interventions

DRUGTadekinig 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.