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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)
Must not have
Subjects requiring ongoing daily corticosteroid therapy at a dose of > 10 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable
Patients with ongoing or past HIV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 90
Awards & highlights
No Placebo-Only Group

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.
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.
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.
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I take more than 10 mg of prednisone daily, not just in short bursts.
Select...
I have HIV.
Select...
I do not have any ongoing serious infections.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participants with a complete response for cytokine release syndrome (CRS)
Secondary study objectives
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
9%
Hyperglycaemia
9%
Hypertriglyceridaemia
9%
Hypertension
9%
Atrial fibrillation
6%
Neutrophil count decreased
6%
Platelet count decreased
6%
Nausea
6%
Other
6%
Bacteraemia
6%
Sepsis
6%
Cough
6%
Rash maculo-papular
3%
Multi-organ failure
3%
Aspiration
3%
Pneumothorax
3%
Lower gastrointestinal haemorrhage
3%
Hypotension
3%
Alanine aminotransferase increased
3%
Delirium
3%
Diarrhoea
3%
Gastroparesis
3%
Hypokalaemia
3%
Laryngeal stenosis
3%
Respiratory failure
3%
Stroke
3%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra + Tocilizumab
Anakinra
Siltuximab
Anakinra + Siltuximab
Tocilizumab
Usual Care

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,343 Total Patients Enrolled
1 Trials studying Cytokine Release Syndrome
32 Patients Enrolled for Cytokine Release Syndrome
Mayur S NarkhedePrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Cytokine Release Syndrome Clinical Trial 2023: Siltuximab Highlights & Side Effects. Trial Name: NCT04975555 — Phase 2
~0 spots leftby Dec 2024
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