Could a simple drug tame the dangerous side effects of CAR-T cancer therapy?
NCT ID NCT06703216
First seen Jul 16, 2026 · Last updated Aug 14, 2026 · Updated 3 times
Summary
This study tests whether giving the drug anakinra early can prevent severe cytokine release syndrome (CRS) in children and young adults with B-cell acute lymphoblastic leukemia (B-ALL) who are receiving CAR-T cell therapy. Participants receive anakinra at the first sign of fever, and the dose is increased if symptoms worsen. The goal is to see if this approach reduces the rate of severe CRS and other immune-related side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- the drug anakinra (Kineret®) given intravenously
- What this could lead to
- If successful, this approach could make CAR-T cell therapy safer by preventing severe cytokine release syndrome, a common and dangerous side effect.
- What could go wrong
- This is a small, early-phase pilot study with no comparison group, so results may not be definitive. Anakinra could also have side effects or fail to reduce severe CRS.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
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
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1 year to 25 years
- Sex
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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.
• Patient consent and parental assent will be obtained. NOTE: Signed consent form must be obtained prior to any study procedures. Labs, marrows or other procedures obtained during routine clinical care maybe used for eligibility if obtained within the protocol required windows. * Patients or their parents/legally authorized representatives (LARs) must have the ability to understand and the willingness to sign a written informed consent document. * The effects of Anakinra on the developing human fetus are largely unknown. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 90 days following completion of Anakinra therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 90 days after completion of administration. Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months) * POCBP 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) * Patients who are between the age of 1 to 26 years * Relapsed or refractory B-acute lymphoblastic leukemia * 2nd or greater marrow relapse OR * Central nervous system (CNS) relapse OR * Any relapse after allogeneic hematopoietic stem cell transplant (HSCT) OR * Refractory disease defined by not achieving an minimal residual disease (MRD)-negative complete remission (CR) after ≥ 2 chemotherapy cycles (1 cycle for relapsed patients) OR * Ineligible for allogeneic HSCT because of: * Comorbid disease * Other contraindications to allogeneic HSCT conditioning * No suitable donor * Prior HSCT * Declines HSCT as the therapeutic option after documented discussion, with expected outcomes, about the role of HSCT with a HSCT physician * Documentation of CD19+ tumor expression in the bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry at relapse, or a recent sample in the case of refractory disease. If the patient has received CD19-directed Pre-emptive anakinra for severe CRS prevention therapy, the flow cytometry should be obtained after this therapy to show CD19 expression. * Adequate organ function defined as: * Alanine aminotransferase (ALT) \< 500 U/L * Bilirubin ≤2.0 mg/dL * Minimum pulmonary reserve defined as ≤Grade 1 dyspnea, pulse oximetry \>92% on room air; diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% (corrected for anemia) if pulmonary function tests (PFTs) are clinically appropriate as determined by the treating investigator. * Left ventricular shortening fraction ≥ 28% or ejection fraction ≥40% confirmed by echocardiography (ECHO), or adequate ventricular function documented by imaging or a cardiologist. * Serum creatinine below the values in the below table, based on age/sex assigned at birth: Maximum Serum Creatinine (mg/dL) Age (years) Male Female 1 to \<2 0.6 0.6 2 to \<6 0.8 0.8 6 to \<10 1.0 1.0 10 to \<13 1.2 1.2 13 to \<16 1.5 1.4 ≥16 1.7 1.4 * Bone marrow disease burden of ≥5% or peripheral blasts within 2 weeks of the start of lymphodepleting chemotherapy * Receiving commercially available tisagenlecleucel
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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
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
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