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Clinical trial

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

ID
Name
UPCC 01422
Description
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).
Trial arms
Trial start
2022-04-17
Estimated PCD
2025-01-01
Trial end
2025-04-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Tadekinig alfa
Size
10
Primary endpoint
Evaluate preliminary safety and feasibility of administering investigational rescue therapies for the treatment of CAR T cell related CRS and CRHLS.
28 days
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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2024-02-09

1 organization

1 product

2 indications

Organization
University of Pennsylvania
Product
Tadekinig alfa
Indication
Cytokine Release Syndrome
Indication
Hemophagocytic lymphohistiocytosis