Status:
RECRUITING
Tadekinig Alfa (IL-18BP) Rescue Therapy for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome
Lead Sponsor:
University of Pennsylvania
Conditions:
CRS - Cytokine Release Syndrome
HLH
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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).
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 dr...
Eligibility Criteria
Inclusion
- 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
- Pregnant or nursing (lactating) women.
- Known hypersensitivity to the active substance or one of the excipients of the investigational product(s).
Key Trial Info
Start Date :
April 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05306080
Start Date
April 17 2022
End Date
April 1 2026
Last Update
February 20 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104