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

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Description

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).

Study Overview

Start Date
April 17, 2022
Completion Date
April 1, 2025
Enrollment
10
Date Posted
March 31, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

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 Criteria:

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

Study Contact Info

Study Contact Name
Joan Gilmore; David Porter, MD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
Detailed Description
This pilot, open-label trial will allow for co-enrollment of subjects participating in University of Pennsylvania-Sponsored, CCI-Initiated CAR T cell studies. As utilization of this investigational drug may be required emergently in the event of qualifying safety events post CAR T cell infusion, subjects may be consented/enrolled at the time they receive an investigational CAR T cell product. If/when use of this investigational drug is deemed clinically necessary, rescue therapy may then be initiated.

Cohort 1: Will allow for the use of Tadekinig alfa, an interleukin-18 binding protein that binds and neutralizes IL-18. IL-18 is a key mediator in systemic inflammatory conditions such as MAS/HLH, which may contribute to the severity of CAR T cell-related cytokine release syndrome (CRS) and HLH-like syndrome (CRHLS) and impact response to standard therapy. In addition, subjects experiencing other IL-18 driven toxicity post CAR T cell therapy which is non-responsive to conventional treatment may also receive rescue therapy with Tadekinig alfa as per clinical discretion.
NCTid (if applicable)
NCT05306080