Can a rheumatoid arthritis drug tame CAR-T's worst side effects?
NCT ID NCT04359784
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested whether anakinra, a drug normally used for rheumatoid arthritis, can prevent two serious side effects of CAR-T cell therapy: cytokine release syndrome (CRS) and nerve damage. The study enrolled 27 adults with B-cell non-Hodgkin lymphoma who were receiving CAR-T treatment. Researchers gave anakinra alongside CAR-T therapy and monitored for CRS and neurotoxicity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anakinra (a drug used for rheumatoid arthritis)
- What this could lead to
- If it works, anakinra could help make CAR-T cell therapy safer by reducing severe side effects like cytokine release syndrome and nerve damage.
- What could go wrong
- This is a small, early-phase trial with only 27 participants, so results may not apply broadly. Anakinra may not prevent these side effects and could have its own risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
27 people
The number who actually took part.
- Started
-
Dec 2021
- Finished
-
Dec 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for B-cell non Hodgkin lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets tough Non-Hodgkin's lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- New antibody tested against aggressive blood cancer
- A smarter steroid schedule might tame Chemotherapy's blood sugar spike
- CAR-T breakthroughs come with infection risks – new study aims to decode them
- Experimental antibody drug shows promise for Hard-to-Treat lymphoma