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Tadekinig Alfa for Cytokine Release Syndrome
Phase < 1
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female patients age ≥ 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety of using an investigational drug to treat CAR T cell related CRS and HLH-like syndrome.
Who is the study for?
This trial is for adults over 18 who are already part of a University of Pennsylvania CAR T cell study. They must be able to have children and agree to use birth control as described in the protocol. Pregnant or nursing women, or those allergic to the drug's ingredients, cannot join.
What is being tested?
The study is testing Tadekinig alfa (IL-18BP) as a rescue therapy for severe immune reactions called CRS and HLH-like syndrome that can happen after CAR T cell treatments. It's an early-stage trial to see if it's safe and workable.
What are the potential side effects?
Since this is an investigational drug, specific side effects aren't fully known yet but may include typical drug reaction symptoms such as allergies, fever, fatigue, headache or potential effects on blood cells and organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate preliminary safety and feasibility of administering investigational rescue therapies for the treatment of CAR T cell related CRS and CRHLS.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tadekinig alfaExperimental Treatment1 Intervention
* Injection #1/Day 1: As clinically indicated in accordance with Figure 1.1-1.
* Repeat Injection(s): 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.
* Retreatment (Optional): May be considered
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,082 Previous Clinical Trials
42,727,352 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Tadekinig alfa
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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