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Monoclonal Antibodies

Emapalumab for Non-Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Matthew 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

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy

Age 18 or older

Must not have

Known history of acute or chronic active hepatitis B or C infection

History of Richter's transformation of CLL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first objective response until date of first documented disease progression or date of death from any cause, assessed up to 24 months post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how effective emapalumab is in preventing cytokine release syndrome in patients with Non-Hodgkin's lymphoma who are undergoing CAR-T cell therapy. Participants will receive

Who is the study for?

This trial is for individuals with various types of Non-Hodgkin's Lymphoma, including Large B-Cell and Follicular Lymphoma. Participants should not have had previous CAR-T therapy or stem cell transplant within a certain time frame, must meet specific blood count criteria, and cannot be pregnant or breastfeeding.

What is being tested?

The study tests if emapalumab can prevent side effects from CAR-T cell therapy in lymphoma patients. It includes lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by axicabtagene ciloleucel (CAR-T) treatment, then emapalumab administration.

What are the potential side effects?

Potential side effects include reactions to infusion such as fever or chills, low blood counts leading to increased infection risk or bleeding, fatigue, nausea, headaches, and possible severe immune responses due to the body's reaction to CAR-T cells.

Eligibility Criteria

Inclusion Criteria

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

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My large B-cell lymphoma didn't respond to my first chemoimmunotherapy or came back within a year.

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I am 18 years old or older.

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It's been over 2 weeks or 5 half-lives since my last systemic therapy, except for immune therapy which had a shorter break.

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I have large B-cell lymphoma that didn't respond to at least two treatments.

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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

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

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I have a history of hepatitis B or C.

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My CLL has transformed into a more aggressive form.

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I have had a stem cell transplant from a donor.

Select...

I do not have any untreated infections.

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I currently have no active brain or spinal cord disease.

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I have received a BCG vaccine in the last 12 weeks.

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I am on ongoing medication for an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first objective response until date of first documented disease progression or date of death from any cause, assessed up to 24 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first objective response until date of first documented disease progression or date of death from any cause, assessed up to 24 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first objective response until date of first documented disease progression or date of death from any cause, assessed up to 24 months post treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of grade 2+ CRS per ASTCT

Secondary study objectives

Objective response rate (ORR)

Rate and severity of ICANS as per ASTCT

Other study objectives

Duration of response (DOR)

Overall survival (OS)

Progression-free Survival (PFS)

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: EmapalumabExperimental Treatment4 Interventions

Leukapheresis will happen within approximately 5 days of eligibility confirmation. Emapalumab is given as a single dose on Day -1 by intravenous infusion over about 1 hour. Lymphodepleting Chemotherapy with cyclophosphamide and fludarabine will occur once a day for 3 days (Days -5 through Day -3) by intravenous infusion over about 2-4 hours. Axicabtagene ciloleucel will be given once on Day 0 by intravenous infusion over about 30 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Emapalumab

2014

Completed Phase 3

~110

Cyclophosphamide

2010

Completed Phase 4

~2310