NCT04150913

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Marcela V. Maus, M.D.,Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non Hodgkin Lymphoma
• Refractory Non-Hodgkin Lymphoma
• Relapsed Non Hodgkin Lymphoma
• Neurotoxicity
• Neurotoxicity Syndromes
• Cytokine Release Syndrome

Interventions

Type	Name	Description
DRUG	Anakinra	Subcutaneous, dosage per protocol. Day 0 through Day 6.
DRUG	Axicabtagene Ciloleucel	Once, intravenous infusion, dosage per protocol

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-10-30
• Completion: 2024-10-31
• First posted: 2019-11-05
• Last updated: 2025-11-25
• Results posted: 2025-05-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study