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Can a simple drug make CAR-T therapy safer?

NCT ID NCT04148430

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether the drug anakinra can prevent or reduce severe side effects like brain problems and cytokine release syndrome caused by CAR-T cell therapy. About 62 adults with certain B-cell blood cancers who are getting CAR-T treatment will receive anakinra. The goal is to see if this approach makes the therapy safer without affecting its cancer-fighting power.

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

62 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Oct 2026

An estimate. End dates often move.

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: * Patients (age \>/= 18) with a diagnosis of relapsed CD19+ B-cell ALL, MCL, or NHL receiving commercially approved CD19-specific CAR T cells (e.g. tisagenleuleucel, axicabtagene, brexucabtagene autoleucel, etc) are eligible for the study Exclusion Criteria: * Patients with uncontrolled systemic fungal and bacterial infections * Patients with known hypersensitivity to E. coli-derived proteins * Women of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) * Women who are pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia B-cell neoplasm B-cell non-Hodgkin lymphoma Burkitt lymphoma mantle cell lymphoma non-Hodgkin lymphoma cytokine release syndrome prevention target toxic encephalopathy prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B cell ALL B-cell lymphoma B-cell non Hodgkin lymphoma

Contacts and locations

Locations

  • Hackensack Meridian Health (Data collection only)

    Hackensack, New Jersey, 07601, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.