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Can a rheumatoid arthritis drug tame CAR-T's worst side effects?

NCT ID NCT04359784

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.