Using Tadekinig Alfa to treat severe side effects from CAR T cell therapy
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
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 |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Drugs / interventions | CAR T |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05306080 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, nursing, or have known hypersensitivity to the investigational drug will not benefit from this study.
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 performed: While this approach is novel in the context of CAR T cell therapy, similar strategies targeting inflammatory responses have shown promise in other settings.
Eligibility criteria
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 this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.