Phase 2 Pilot Study to Evaluate Efficacy and Safety of Anakinra to Prevent CD19-Targeted CAR-T Cell-Related Cytokine Release Syndrome (CRS) and Neurotoxicity in Patients With B Cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Mar 3, 2024
  • participants needed
    25
  • sponsor
    Fred Hutchinson Cancer Center
Updated on 14 October 2022
cell therapy

Summary

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 non-Hodgkin 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.

Description

OUTLINE

Patients receive anakinra subcutaneously (SC) daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0.

After completion of lisocabtagene maraleucel infusion, patients are followed up periodically for up to 90 days.

Details
Condition B-Cell Non-Hodgkin Lymphoma
Treatment Anakinra, Axicabtagene Ciloleucel, lisocabtagene maraleucel
Clinical Study IdentifierNCT04359784
SponsorFred Hutchinson Cancer Center
Last Modified on14 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must be 18 years of age or older
Karnofsky performance status of >= 60%
Patients with B-cell non-Hodgkin lymphoma (B-NHL) and eligible for treatment with liso-cel. Patients treated with non-conforming (out-of-specification) liso-cell may remain on study
Negative serum pregnancy test within 2 weeks of enrollment for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
Fertile male and female subjects must be willing to use an effective contraceptive method before, during, and for at least 4 months after the last dose of anakinra
Ability to understand and provide informed consent

Exclusion Criteria

Subjects requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable
Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the principal investigator (PI)
Serum creatinine > 2.5 mg/dL
Known hypersensitivity to Escherichia € coli-derived proteins, anakinra, or to any component of the product
Major organ dysfunction defined as
Significant hepatic dysfunction (Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 5x upper limit of normal; bilirubin > 3.0 mg/dL) unless due to malignancy or Gilbert's syndrome in the opinion of the PI or designee
Subjects with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing. Those with a forced expiratory volume in 1 second (FEV1) of < 50% of predicted or diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) < 40% will be excluded
Significant cardiovascular abnormalities as defined by any one of the following: New York Heart Association (NYHA) class III or IV congestive heart failure, clinically significant hypotension, uncontrolled symptomatic coronary artery disease, or a documented ejection fraction of < 35%
Uncontrolled serious and active infection
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