NCT05306080 Tadekinig Alfa (IL-18BP) Rescue Therapy for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome
| NCT ID | NCT05306080 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Pennsylvania |
| Condition | CRS - Cytokine Release Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2022-04-17 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2022-04-17 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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).
Frequently Asked Questions
Who can join the NCT05306080 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CRS - Cytokine Release Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05306080 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05306080 currently recruiting?
Yes, NCT05306080 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Pennsylvania to inquire about joining.
Where is the NCT05306080 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05306080 clinical trial?
NCT05306080 is sponsored by University of Pennsylvania. The trial plans to enroll 10 participants.