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Siltuximab for Non-Hodgkin's Lymphoma

Phase 1

Waitlist Available

Led By Timothy J Voorhees, MD, MSCR

Research Sponsored by Timothy Voorhees

Eligibility Criteria Checklist

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

Must have

Eligible for standard of care CD19.CAR-T cell therapy including axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel and lisocabtagene maraleucel)

FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Any subject with grade >= 2 CRS after CD19.CAR-T cell therapy

Must not have

FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Prior history of a dose limiting toxicity (see section 6.5) due to siltuximab infusion according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) criteria v5.0

Patients with history of clinically relevant and active CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of treatment initiation to date of death due to all causes, assessed up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if siltuximab can help reduce complications of CD19.CAR-T cell therapy.

Who is the study for?

Adults with CD19 positive non-Hodgkin lymphoma eligible for standard CAR-T cell therapy can join this trial. They must have certain blood and organ function levels, not be pregnant or breastfeeding, use contraception if of childbearing potential, and cannot have active central nervous system lymphoma or uncontrolled illnesses.

What is being tested?

The trial is testing siltuximab's ability to prevent cytokine release syndrome (CRS) and neurotoxicity in patients undergoing CAR-T cell therapy. Siltuximab is an antibody that targets IL-6, a body chemical linked to these side effects.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response such as inflammation in various organs due to the suppression of IL-6 by siltuximab. Specific side effect profiles will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

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I am eligible for a specific CAR-T cell therapy.

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I have a reaction of grade 2 or higher after CAR-T cell therapy.

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I have had mild brain side effects from treatment for more than 12 hours.

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I am 18 years old or older.

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I am a male and will use effective birth control during and for 12 months after the study.

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I have been diagnosed with non-Hodgkin lymphoma.

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My cancer can be measured and is larger than 1.5 cm or is in my bone marrow.

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I have a reaction of grade 2 or higher after CAR-T cell therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe side effects from siltuximab treatment before.

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I do not have active brain conditions like epilepsy, severe strokes, or Parkinson's.

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I had a severe reaction to my first siltuximab infusion.

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I do not have any severe uncontrolled illnesses like heart failure or very high blood pressure.

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I am HIV positive.

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My lymphoma has not spread to my brain or spinal cord, or if it has, it's been in remission for at least 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of treatment initiation to date of death due to all causes, assessed up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of treatment initiation to date of death due to all causes, assessed up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of treatment initiation to date of death due to all causes, assessed up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency and nature of adverse events associated with siltuximab prophylaxis prior to CD19 directed chimeric antigen receptor T-cell therapy (CD19.CAR-T) cell therapy

Secondary study objectives

Frequency and nature of adverse events associated with siltuximab treatment of cytokine release syndrome (CRS) and/or immune effector cell associated neurotoxicity syndrome (ICANS)

Incidence of all grade CRS and grade >= 3 CRS

Incidence of all grade ICANS and grade >= 3 ICANS

+4 more

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: Treatment (siltuximab, biospecimen)Experimental Treatment4 Interventions

Patients receive siltuximab IV prior to CE19.CAR-T cell therapy and as clinically indicated on study. Patients undergo CT scan or PET scan throughout the trial. Patients also undergo blood sample collection during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790