Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 and up

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

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment10 (estimated)
SponsorUniversity of Pennsylvania
Academic / other
Drugs / interventionsCAR T
Locations1 site (Philadelphia, Pennsylvania)
StatusRecruiting
StartedApril 17, 2022
Main results expectedJanuary 2028
Study endsApril 2028
Registry record updatedMarch 3, 2026
Trial IDNCT05306080 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

  • University of Pennsylvania
    Philadelphia, Pennsylvania, United States
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.