Active — Not RecruitingPhase 2

A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy

United States62 participantsStarted 2019-10-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities

Timeframe: 4 weeks

Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation

Timeframe: 28 days from the start of treatment

Trial details

NCT IDNCT04148430

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More B Cell ALL trials