Phase 2
Completed N=25
Anakinra for the Prevention of Cytokine Release Syndrome and Neurotoxicity in Patients With B-Cell Non-Hodgkin Lymphoma Receiving CD19-Targeted CAR-T Cell Therapy
Source: ClinicalTrials.gov NCT04359784 ↗Enrolled (actual)
25
Serious AEs
60.0%
Results posted
Oct 2025
Primary outcomePrimary: Absence of Any Grade Cytokine Release Syndrome (CRS) — 16; 9 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Any Grade Cytokine Release Syndrome (CRS) |
16; 9 | — |
| SECONDARY CRS Grade |
9; 8; 7; 1 | — |
| SECONDARY ICANS Grade |
16; 4; 2; 3 | — |
| SECONDARY Rate of Hospitalization After Liso-cel Treatment |
18 | — |
| SECONDARY Duration of Hospitalization After Liso-cel Treatment |
6; 8 | — |
| SECONDARY Corticosteroid Usage After Liso-cel Treatment |
10 | — |
| SECONDARY Disease Response to Liso-cel |
8; 5; 2; 4; 6 | — |
| SECONDARY Adverse Events (AEs) |
25 | — |
Eligibility Criteria
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)
- Known hypersensitivity to Escherichia € coli-derived proteins, anakinra, or to any component of the product
- Major organ dysfunction defined as:
- Serum creatinine > 2.5 mg/dL
- 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
Data sourced from ClinicalTrials.gov (NCT04359784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.