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Monoclonal Antibodies

Emapalumab for Non-Hodgkin's Lymphoma

Phase 2
Waitlist Available
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. Or adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
* At least 1 measurable lesion per Lugano at time of screening.
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

Summary

This research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL). The research study involves the following study interventions: * Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy) * Axicabtagene Ciloleucel * Emapalumab

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

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
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)

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
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Emapalumab
2014
Completed Phase 3
~110
Axicabtagene Ciloleucel
2020
Completed Phase 2
~510
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Swedish Orphan BiovitrumIndustry Sponsor
96 Previous Clinical Trials
12,636 Total Patients Enrolled
Marcela V. Maus, M.D.,Ph.D.Lead Sponsor
5 Previous Clinical Trials
84 Total Patients Enrolled
Matthew Frigault, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
24 Total Patients Enrolled
~19 spots leftby Aug 2026
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