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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

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

0 / 1Eligibility criteria met