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Siltuximab for CRS and ICANS Related to CAR-T Therapy

Phase 2

Recruiting

Led By Mayur S Narkhede

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with hepatitis C virus (HCV) can be included if they have completed therapy for hepatitis C with undetectable HCV RNA viral load

Adequate organ function as defined below unless attributed to disease involvement.Acceptable window for assessing adequate organ function is 7 days to 30 days before planned CAR T-cell infusion with day 0 as the planned day of CAR T-cell infusion.Adequate liver function (bilirubin < 2mg/dL, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) <3 x ULN), adequate kidney function (crcl > 30ml/min using Cockcroft-Gault, based on actual weight) and adequate hematological parameters (Absolute neutrophil count ≥ 1,000/µL, Hemoglobin > 8, Platelet Count ≥ 50,000/ µL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through day 90

Awards & highlights

Study Summary

This trial will test whether siltuximab can lessen the severity of CRS and ICANS in patients receiving CAR T-cell therapy for blood cancer.

Who is the study for?

This trial is for patients with certain blood cancers who are getting CAR-T cell therapy and can handle a washout period before treatment. They must have good liver, kidney, and blood function, not be pregnant or HIV positive, and agree to use effective contraception.Check my eligibility

What is being tested?

The study tests if siltuximab can reduce the severity of CRS and ICANS in patients undergoing CAR-T cell therapy for hematological malignancies like lymphoma or leukemia.See study design

What are the potential side effects?

Siltuximab may cause side effects such as allergic reactions, infections due to immune suppression, headache, dizziness, nausea, vomiting, rash or itching at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have hepatitis C but have completed treatment and now have an undetectable viral load.

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My liver, kidneys, and blood counts are within the required ranges for CAR T-cell therapy.

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I am willing to follow all study requirements, including IV treatments and possible overnight stays.

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I can stop my current cancer treatments for a short period before receiving CAR T-cell therapy.

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I am scheduled for CAR T-cell therapy for my lymphoma or leukemia as approved by the USFDA.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participants with a complete response for cytokine release syndrome (CRS)

Secondary outcome measures

Participants experiencing adverse events from Siltuximab

Participants with a response for Immune effector Cell Associated Neurotoxicity Syndrome (ICANS)

Participants with response to CAR T-cell therapy

Side effects data

From 2021 Phase 3 trial • 342 Patients • NCT04330638

22%

Constipation

16%

Lung infection

Hyperglycaemia

Hypertriglyceridaemia

Hypertension

Atrial fibrillation

Other

Bacteraemia

Platelet count decreased

Neutrophil count decreased

Nausea

Sepsis

Cough

Rash maculo-papular

Aspiration

Pneumothorax

Lower gastrointestinal haemorrhage

Gastroparesis

Alanine aminotransferase increased

Multi-organ failure

Diarrhoea

Hypokalaemia

Hypotension

Delirium

Laryngeal stenosis

Respiratory failure

Stroke

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Anakinra + Tocilizumab

Anakinra

Siltuximab

Anakinra + Siltuximab

Tocilizumab

Usual Care

Trial Design

1Treatment groups

Experimental Treatment

Group I: SiltuximabExperimental Treatment1 Intervention

Patients who experience CRS/ICANS will receive this treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Siltuximab

2011

Completed Phase 3

~1190

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,324 Total Patients Enrolled

Mayur S NarkhedePrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Non-Hodgkin's Lymphoma Clinical Trial 2023: Siltuximab Highlights & Side Effects. Trial Name: NCT04975555 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the estimated number of participants included in this research?

"Confirmed. According to the records on clinicaltrials.gov, this trial is actively searching for 30 enrollees at 1 medical centre - with its first posting date being November 15th 2021 and its final edit occurring two days later."

Answered by AI

What prior experiments have explored the efficacy of Siltuximab?

"Currently, 4 different trials are observing the effects of siltuximab. Not one is in its final phase 3; however there are 6 sites across New york City that have started testing this medication's efficacy."

Answered by AI

Does this clinical trial currently have openings for participants?

"Affirmative. The clinical trial data hosted on clinicialtrials.gov verifies that this experiment commenced recruitment as of November 15th 2021 and was most recently revised on the 17th of November 2021. Currently, 30 individuals are needed for participation at a single medical site."

Answered by AI

What evidence exists for the safety of Siltuximab in humans?

"Our team has determined that siltuximab's safety score is a 2, as the drug is currently in its second phase of clinical trials and there are data points that suggest it can be safe but none to support its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy

Mayur Narkhede 2021. "Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04975555.

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