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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

B Cell ALL B-cell Lymphoma B-cell Non Hodgkin Lymphoma Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Tumor Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hackensack Meridian Health (Data collection only), Hackensack, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anakinra

Drug

100mg subcutaneous

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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2026
Study completion: 2026
First posted: Nov 1, 2019
Registry last updated: Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting