Clinical Trials Using Anakinra

Clinical trials are research studies that involve people. The clinical trials on this list are studying Anakinra. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-5 of 5
  • Axicabtagene Ciloleucel and Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity in Recurrent or Refractory B Cell Lymphoma Patients

    This phase II trial studies how well axicabtagene ciloleucel in combination with anakinra works in preventing chimeric antigen receptor (CAR)-T cell mediated neurotoxicity in patients with B cell lymphoma that has come back (recurrent) or not responded to treatment (refractory). Axicabtagene ciloleucel is a drug that uses patient's own immune cells, called T cells, to try to kill cancerous cells. The primary risks observed in interventions like axicabtagene ciloleucel are cytokine release syndrome (CRS) and neurological toxicities. CRS is a group of symptoms caused by the release of chemicals from cells during the infusion. This can include nausea, headache, rapid heartbeat, shortness of breath, kidney damage, and rash. It is thought that a protein called IL-1 may play a critical role in the formation of both CRS and neurological toxicities. Anakinra is a type of inhibitor that works by inhibiting (blocking) the protein IL-1. Giving axicabtagene ciloleucel in combination with anakinra may work to block this protein and decrease the risk of experiencing CRS and neurological toxicity.
    Location: 3 locations

  • Anakinra for the Reduction of CAR-T Toxicity in Patients with Relapsed or Refractory Large B-cell Lymphoma

    This phase II trial studies the side effects and best dose of anakinra and to see how well it works in reducing side effects (toxicity) associated with a CAR-T cell treatment called axicabtagene ciloleucel in patients with large B-cell lymphoma that has come back (relapsed) or has not responded to treatment (refractory). Anakinra is a drug typically used to treat rheumatoid arthritis but may also help in reducing CAR-T cell therapy toxicity. Giving anakinra in combination with axicabtagene ciloleucel may help control relapsed or refractory large B-cell lymphoma.
    Location: M D Anderson Cancer Center, Houston, Texas

  • A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy and to Treat Systemic Inflammation Associated with COVID-19

    This phase II trial studies how well anakinra works in preventing severe decreased brain function (neurotoxicity), a dangerous condition called cytokine release syndrome (CRS) caused by CAR-T cells, or inflammation associated with COVID-19 infection. T cells (a type of immune cells) are taken from a patient’s blood. Then the gene for a special receptor that binds to a certain protein on the patient’s cancer cells is added in the laboratory. The special receptor is called a chimeric antigen receptor (CAR) and this type of modified T cells are called CAR-T cells. Cytokines are proteins that control body’s inflammatory response. In CRS, a large amount of cytokines is released into the blood, which may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and / or affect the way lungs / liver / kidneys work. CAR-T cell therapy may also cause brain-related symptoms (neurotoxicity), such as dizziness, weakness, confusion, difficulty speaking, and / or possible paralysis, and / or coma. Sometimes the immune system can become overactive in fighting the COVID-19 infection (causing a severe inflammatory reaction), and when a person’s immune system gets out of control that person can become very ill. Anakinra works by blocking the inflammatory cytokine, called IL-1 (interleukin-1) that is released into the blood during or shortly after CAR-T cell therapy or during COVID-19 infection, and causes an inflammatory (swelling) reaction. Anakinra may prevent or reverse the severe side effects of CAR-T cell therapy or COVID-19 infection.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients with Recurrent or Refractory Large B-cell Lymphoma

    This phase II trial studies how well anakinra works in preventing severe chimeric antigen receptor T-cell-related encephalopathy syndrome after chimeric antigen receptor T-cell therapy in patients with large B-cell lymphoma that has come back or has not responded to treatment. Immunosuppressive therapy, such as anakinra, is used to decrease the body’s immune response, which may prevent severe chimeric antigen receptor T-cell-related encephalopathy syndrome.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Anakinra for the Prevention of Cytokine Release Syndrome and Neurotoxicity in Patients with B-Cell Lymphoma Receiving CD19-Targeted CAR-T Cell Therapy

    This phase II trial studies how well anakinra works in decreasing the occurrence of cytokine release syndrome (CRS) and damage to the nerves (neurotoxicity) in patients with B-cell lymphoma who are receiving CD-19 targeted chimeric antigen receptor T-cell (CAR-T) therapy. CAR-T cell therapy may be complicated by two potentially life-threatening side effects: CRS and neurotoxicity. Anakinra is a drug typically used to treat rheumatoid arthritis, but may also help in preventing CAR-T cell-related cytokine release syndrome and neurotoxicity.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington