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

NCT04150913 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-11-25

Study results available
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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.

Conditions

Interventions

DRUG

Anakinra

Subcutaneous, dosage per protocol. Day 0 through Day 6.

DRUG

Axicabtagene Ciloleucel

Once, intravenous infusion, dosage per protocol

Sponsors & Collaborators

  • Kite, A Gilead Company

    collaborator INDUSTRY

  • Marcela V. Maus, M.D.,Ph.D.

    lead OTHER

Principal Investigators

  • Matt J Frigault, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2023-10-30
Completion
2024-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04150913 on ClinicalTrials.gov