A Phase II Study of IL-1 Receptor Antagonist Anakinra to Prevent Severe Neurotoxicity and Cytokine Release Syndrome in Patients Receiving CD19-Specific Chimeric Antigen Receptor (CAR) T Cells
Overview
- Phase
- Phase 2
- Intervention
- Anakinra
- Conditions
- B Cell ALL
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
This study is being done to see if the investigational drug, anakinra, prevent or reverse the severe side effects caused by CAR-T cell therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients (age \>/= 18) with a diagnosis of relapsed CD19+ B-cell ALL, MCL, or NHL receiving commercially approved CD19-specific CAR T cells (e.g. tisagenleuleucel, axicabtagene, brexucabtagene autoleucel, etc) are eligible for the study
Exclusion Criteria
- •Patients with uncontrolled systemic fungal and bacterial infections
- •Patients with known hypersensitivity to E. coli-derived proteins
- •Women of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
- •Women who are pregnant or breastfeeding
Arms & Interventions
Arm 1 (CART Cell Group)
Cohort 1 Patients will receive anakinra 100mg s.c. every 12 hours starting on day 2 post CAR T cell infusion, or after 2 documented fevers of ≥38.5° C prior to day 2, whichever time point is earlier. Anakinra will be continued for 10 days. Cohort 2 Patients will receive anakinra 100mg s.c. daily on day 0 of T cell infusion, and continue anakinra daily for 7 days
Intervention: Anakinra
Outcomes
Primary Outcomes
Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities
Time Frame: 4 weeks
Determine the rate of severe neurotoxicities, \>/= Grade 3 or any grade seizure, within the first 4 weeks of treatment with prophylactic use of anakinra in participants receiving CD19-specific CAR T cells
Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation
Time Frame: 28 days from the start of treatment
proportion of patients able to avoid death or mechanical ventilation within 28 days from the start of the treatment.