NCT05306080 · University of Pennsylvania
Tadekinig Alfa (IL-18BP) Rescue Therapy for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome
What this study is about
This is a pilot, where both patients and doctors know the treatment given study to assess the safety and feasibility of using experimental drug(s) as rescue therapies for CAR T cell related CRS and HLH-like syndrome (CRHLS).
View original scientific 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).
Interventions
DRUG
Tadekinig 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.
Primary outcome measures
Evaluate preliminary safety and feasibility of administering investigational rescue therapies for the treatment of CAR T cell related CRS and CRHLS.
Time frame: 28 days
Type, frequency, and severity of AEs/SAEs determined to be related to the rescue therapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations