CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Anakinra +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04150913
NCT04150913Phase 2Completed

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

Marcela V. Maus, M.D.,Ph.D.·interventional·Posted Nov 5, 2019·Updated Nov 25, 2025

In Brief

A Phase 2 clinical trial evaluating Anakinra and Axicabtagene Ciloleucel for Non Hodgkin Lymphoma and 5 related conditions. Completed, enrolled 15 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 5, 2019
Enrollment StartOct 1, 2020
Primary CompletionOct 30, 2023
Study CompletionOct 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.7 years ago

Interventions

Anakinradrug

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

Axicabtagene Ciloleuceldrug

Once, intravenous infusion, dosage per protocol