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A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity

NCT04150913•Marcela V. Maus, M.D.,Ph.D.

Summary

This research study is studying the combination of anakinra and axicabtagene ciloleucel to reduce the occurrence of the side effects Cytokine Release Syndrome (CRS) and neurologic toxicities with relapsed or refractory Non-Hodgkin lymphoma (NHL). * Relapsed NHL is the condition of returned Non-Hodgkin lymphoma. * Refractory NHL is the condition of previous treatment resistant Non-Hodgkin lymphoma. * Cytokine Release Syndrome (CRS) is a group of side effect symptoms that can include nausea, headache, rapid heartbeat, shortness of breath, kidney damage, and rash. * Neurologic toxicity is nervous system disorder characterized by confusion This research study involves two drugs: * Anakinra * Axicabtagene Ciloleucel.

Detailed Description

This Phase 2, single center, open-label research study is studying the combination of Anakinra and Axicabtagene Ciloleucel to reduce the occurrence of the side effects Cytokine Release Syndrome (CRS) and neurologic toxicities in people with relapsed or refractory Non-Hodgkin lymphoma (NHL). The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * This research study involves two drugs: * Anakinra * Axicabtagene Ciloleucel * A total of 20 participants are anticipated to be enrolled to this trial * The U.S. Food and Drug Administration (FDA) has not approved anakinra for use in treatment of Non-Hodgkin lymphoma (NHL).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+7 more criteria

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
+14 more criteria

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

October 1, 2020

Primary Completion Date

October 30, 2023

Completion Date

October 31, 2024

Last Updated

November 25, 2025

Enrollment

ACTUAL participants

Conditions

Non Hodgkin LymphomaRefractory Non-Hodgkin LymphomaRelapsed Non Hodgkin LymphomaNeurotoxicityNeurotoxicity SyndromesCytokine Release Syndrome

Interventions

Anakinra

DRUG

Axicabtagene Ciloleucel

DRUG

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

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RECRUITINGPHASE1

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

NCT06026319

Non-hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL

Familial Investigations of Childhood Cancer Predisposition