UPCC 01422 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
Investigating Rescue Treatments for Reactions to Cancer Therapy
Brief description of study
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).
Detailed description of study
This pilot, open-label trial will allow for co-enrollment of subjects participating in University of Pennsylvania-Sponsored, CCI-Initiated CAR T cell studies. As utilization of this investigational drug may be required emergently in the event of qualifying safety events post CAR T cell infusion, subjects may be consented/enrolled at the time they receive an investigational CAR T cell product. If/when use of this investigational drug is deemed clinically necessary, rescue therapy may then be initiated.
Cohort 1: Will allow for the use of Tadekinig alfa, an interleukin-18 binding protein that binds and neutralizes IL-18. IL-18 is a key mediator in systemic inflammatory conditions such as MAS/HLH, which may contribute to the severity of CAR T cell-related cytokine release syndrome (CRS) and HLH-like syndrome (CRHLS) and impact response to standard therapy. In addition, subjects experiencing other IL-18 driven toxicity post CAR T cell therapy which is non-responsive to conventional treatment may also receive rescue therapy with Tadekinig alfa as per clinical discretion.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: CRS - Cytokine Release Syndrome, HLH
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant or nursing (lactating) women.
- Known hypersensitivity to the active substance or one of the excipients of the investigational product(s).
This study investigates the safety and feasibility of using investigational medications as rescue therapies for conditions related to CAR T cell therapy, specifically cytokine release syndrome (CRS) and hemophagocytic lymphohistiocytosis-like syndrome (CRHLS). These conditions can occur after receiving CAR T cell therapy, which is a treatment that modifies a patient's own immune cells to attack cancer cells. The study will focus on understanding how these investigational treatments can be used in emergencies when patients experience severe reactions post-therapy.
Participants in this study may receive Tadekinig alfa, an interleukin-18 binding protein that works by neutralizing IL-18, a molecule that can cause inflammation. This investigational medication is intended for use in patients who experience severe inflammatory responses that do not respond to standard treatments. The study will observe how well the investigational medication works in reducing symptoms and improving patient outcomes.
- Who can participate: Adults aged 18 and older who are enrolled in a University of Pennsylvania-Sponsored, CCI-Initiated CAR T cell clinical trial may participate. Participants must provide informed consent and agree to use birth control if of reproductive potential.
- Study details: Participants will receive investigational medications as rescue therapies if they experience severe reactions after CAR T cell therapy. The study will monitor the safety and effectiveness of these treatments.
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