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CAR T-cell Therapy

Anakinra for Neurotoxicity Prevention in CAR-T Cell Therapy

Phase 2

Waitlist Available

Led By Matt J Frigault, MD

Research Sponsored by Marcela V. Maus, M.D.,Ph.D.

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including specific subtypes

Must not have

Uncontrolled or severe infections

Expected or possible requirement for urgent therapy within 6 weeks due to ongoing or impending oncologic emergency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up infusion date to the date of disease progression or death from any cause up 100 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is being done to study the combination of these drugs to see if it can reduce the occurrence of Cytokine Release Syndrome (CRS) and neurologic toxicities.

Who is the study for?

This trial is for adults over 18 with relapsed or resistant large B-cell lymphoma after two prior therapies. They must have at least one measurable lesion, stable recovery from previous treatments, good organ function, and no severe allergies to study drugs. Women of childbearing age need a negative pregnancy test and agree to use contraception.

What is being tested?

The study tests if anakinra can reduce side effects like Cytokine Release Syndrome (CRS) and neurologic toxicities in patients receiving axicabtagene ciloleucel for Non-Hodgkin lymphoma. It's seeing if this combination is safer than the current treatment.

What are the potential side effects?

Possible side effects include nausea, headache, rapid heartbeat, shortness of breath, kidney damage, rash due to CRS; confusion from neurotoxicity; plus any typical reactions related to anakinra or axicabtagene ciloleucel.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My large B-cell lymphoma has not responded to at least two treatments.

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I am not pregnant and agree to use birth control.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have any severe or uncontrolled infections.

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I might need urgent cancer treatment soon due to a serious risk.

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I have an autoimmune disease that has damaged organs or needed strong medication in the last 2 years.

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I have a history of HIV or active hepatitis B or C.

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I have cancer cells in my spinal fluid or brain, or certain brain disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ infusion date to the date of disease progression or death from any cause up 100 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~infusion date to the date of disease progression or death from any cause up 100 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and infusion date to the date of disease progression or death from any cause up 100 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of neurotoxicity as per CTCAE v4.03 criteria

Secondary study objectives

Duration of Response

Number of Participants with Adverse Events CTCAE version 4.03 Grade 3 or higher

Objective Response Rate

+2 more

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132

19%

Acute Kidney Injury

11%

Ascites

Nausea

Urinary tract infection

Hematemesis

Upper GI hemorrhage

Clostridium difficile infection

Hepatic failure

Encephalopathy

C. difficile infection

Respiratory Failure

Peritonitis

Esophageal varices hemorrhage

Tachycardia

Multiple Organ Dysfunction Syndrome (MODS)

Viremia

Baceteremia

100%

80%

60%

40%

20%

Study treatment Arm

Anakinra & Pentoxifylline & Zinc Sulfate

Methylprednisolone

Observational

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: Anakinra and Axicabtagene CiloleucelExperimental Treatment2 Interventions

Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axicabtagene Ciloleucel

2020

Completed Phase 2

~510

Anakinra

2016

Completed Phase 4

~1320