Can a common arthritis drug tame CAR-T's dangerous side effects?
NCT ID NCT04150913
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested whether adding the drug anakinra (Kineret) to standard CAR-T cell therapy could prevent nerve toxicity in 15 people with relapsed or refractory non-Hodgkin lymphoma. Participants received anakinra injections for a week alongside their CAR-T infusion. The goal was to reduce severe side effects like confusion or seizures without harming the cancer-fighting power of the treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anakinra (Kineret) and axicabtagene ciloleucel (CAR-T cells)
- What this could lead to
- If it works, this could reduce serious nerve side effects from CAR-T therapy, making the treatment safer for lymphoma patients.
- What could go wrong
- This is a small, early-phase trial with only 15 participants, so results may not apply broadly. The drug may not reduce neurotoxicity as hoped.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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15 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Oct 2024
- Lead sponsor
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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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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. * At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma 1. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy * At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy however steroids only require a 7-day washout. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). * Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia) * Age 18 or older * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * ANC ≥1000/uL * Platelet count ≥75,000/uL * Absolute lymphocyte count ≥100/uL * Adequate renal, hepatic, pulmonary and cardiac function defined as: * Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min * Serum ALT/AST ≤2.5 ULN * Total bilirubin ≤1.5 mg/dl, except in subjects with Gilbert's syndrome. * Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion, and no clinically significant ECG findings * No clinically significant pleural effusion * Baseline oxygen saturation \>92% on room air * Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria * History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years * History of Richter's transformation of CLL * Autologous stem cell transplant within 6 weeks of planned axicabtagene ciloleucel infusion * History of allogeneic stem cell transplantation * Prior CD19 targeted therapy with the exception of subjects who received axicabtagene ciloleucel in this study and are eligible for re-treatment * Prior chimeric antigen receptor therapy or other genetically modified T cell therapy * History of severe, immediate hypersensitivity reaction attributed to aminoglycosides * Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. * History of HIV infection or acute or chronic active hepatitis B or C infection. Subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines. * Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted * Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma or primary CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases * History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement * Subjects with cardiac atrial or cardiac ventricular lymphoma involvement * History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment * Expected or possible requirement for urgent therapy within 6 weeks due to ongoing or impending oncologic emergency (eg, tumor mass effect, tumor lysis syndrome) * Primary immunodeficiency * History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment * Any medical condition likely to interfere with assessment of safety or efficacy of study treatment * History of severe immediate hypersensitivity reaction to any of the agents used in this study * Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen * Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential * Subjects of both genders who are not willing to practice birth control from the time of consent through 6 months after the completion of axicabtagene ciloleucel * In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation * History of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
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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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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
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Other studies related to the condition(s) this trial covers.
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