A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
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.
Arms and Interventions
|Experimental: 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
Primary Outcome Measures
- Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities [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 [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.
- 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
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
Contacts and Locations
|Hackensack Meridian Health (Data collection only)
|Memorial Sloan Kettering Cancer Center
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- Principal Investigator: Jae Park, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)None provided.