Tadekinig Alfa (IL-18BP) Rescue Therapy for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnant or nursing (lactating) women.
Known hypersensitivity to the active substance or one of the excipients of the investigational product(s).
Trial design
Design model
Single group
Treatments tested in this trial
Tadekinig alfa (IL-18BP)
DrugTadekinig 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Tadekinig alfaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate preliminary safety and feasibility of administering investigational rescue therapies for the treatment of CAR T cell related CRS and CRHLS.
Type, frequency, and severity of AEs/SAEs determined to be related to the rescue therapy.
Time frame
28 daysSponsors and contacts
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Source ClinicalTrials.gov