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Verified·NCT04148430Synced: Nov 3, 2026Active, not recruitingPhase 2

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
This is not medical advice. Consult your specialist.
View the official record on ClinicalTrials.gov →