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

Plain Language Summary

Simplified for easier understanding

This trial tests tadekinig alfa (a protein that blocks an inflammatory signal called IL-18) as a rescue therapy for patients who develop severe side effects from CAR T cell therapy — specifically cytokine release syndrome (CRS, a dangerous immune overreaction) or a related life-threatening condition called HLH-like syndrome. **You may be eligible if...** - You are 18 or older and are already enrolled in a CAR T cell clinical trial at the University of Pennsylvania - You have developed or are at risk for CRS or HLH-like syndrome after receiving CAR T cells - You are willing to use contraception if applicable **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a known allergy to tadekinig alfa or its components Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.