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

Plain-language summary

This Phase 2 study tests whether the investigational drug anakinra can prevent or reverse the severe side effects caused by CAR-T cell therapy. Eligible participants are adults aged 18 or older with relapsed CD19-positive B-cell ALL, MCL or NHL who are receiving a commercially approved CD19-directed CAR T-cell product such as tisagenlecleucel, axicabtagene or brexucabtagene autoleucel.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Active, not recruiting

Sponsor

Memorial Sloan Kettering Cancer Center

Intervention

Anakinra

Start date

10/30/2019

Estimated completion

10/1/2026

Countries

United States

Locations

• Hackensack, United States
• New York, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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