Using Tadekinig Alfa to treat severe side effects from CAR T cell therapy
Official title: Pilot, Open-Label Study Evaluating the Safety and Feasibility of Using Rescue Therapies for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome
Run by University of Pennsylvania · NCT05306080 · Data updated 2026-11-12
This study is testing if a new drug called Tadekinig alfa can help people who have severe side effects from CAR T cell therapy feel better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Drugs / interventions | CAR T |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | April 17, 2022 |
| Main results expected | January 2028 |
| Study ends | April 2028 |
| Registry record updated | March 3, 2026 |
| Trial ID | NCT05306080 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are co-enrolled in a University of Pennsylvania-sponsored CAR T cell clinical trial.
✕Probably not a fit
Patients who are pregnant, nursing, or have known hypersensitivity to the investigational drug will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot, open-label trial evaluates the safety and feasibility of Tadekinig alfa, an interleukin-18 binding protein, as a rescue therapy for patients experiencing cytokine release syndrome (CRS) and HLH-like syndrome following CAR T cell therapy. Participants will be co-enrolled in University of Pennsylvania-sponsored CAR T cell studies and may receive the investigational drug if they experience qualifying safety events post-infusion. The study aims to determine if Tadekinig alfa can effectively mitigate severe inflammatory responses associated with CAR T cell treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from severe inflammatory responses after CAR T cell therapy.
How similar studies have gone: While this approach is novel in the context of CAR T cell therapy, similar strategies targeting inflammatory responses have shown promise in other settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed, written informed consent 2. Male or female patients age ≥ 18 years 3. Have been co-enrolled in a University of Pennsylvania-Sponsored, CCI-Initiated CAR T cell clinical trial. 4. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol Exclusion Criteria: 1. Pregnant or nursing (lactating) women. 2. Known hypersensitivity to the active substance or one of the excipients of the investigational product(s).
Where it's running
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University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.