Recruiting
Early Phase 1

Tadekinig Alfa

Sponsor:

University of Pennsylvania

Code:

NCT05306080

Conditions

CRS - Cytokine Release Syndrome

HLH

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tadekinig alfa (IL-18BP)

Study Details

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).

Conditions

CRS - Cytokine Release Syndrome

HLH

Study ID

NCT05306080

Start date

Apr 17, 2022

Status verified date

Feb, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tadekinig alfa

  • Injection #1/Day 1: As clinically indicated in accordance with Figure 1.1-1.
  • Repeat Injection(s): 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.
  • Retreatment (Optional): May be considered

Interventions

Tadekinig alfa (IL-18BP)

Tadekinig 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.

Primary outcome measure

  • Evaluate preliminary safety and feasibility of administering investigational rescue therapies for the treatment of CAR T cell related CRS and CRHLS. [ Time Frame: 28 days ]

Central Contacts and Locations

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Joan Gilmore

215-573-2540joan.gilmore@pennmedicine.upenn.edu

Principal Investigator:

David Porter, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-03.