RecruitingPhase 2NCT06550141

Emapalumab Prevention of CAR-T Cell Associated Toxicities

A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities


Sponsor

Marcela V. Maus, M.D.,Ph.D.

Enrollment

28 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called emapalumab can help prevent dangerous side effects — specifically cytokine release syndrome (CRS) and neurological toxicities — that can occur after CAR-T cell therapy. CAR-T is a powerful immune cell treatment for large B-cell lymphoma (a blood cancer), and these side effects can be life-threatening. Emapalumab blocks a molecule called interferon-gamma that drives these reactions. **You may be eligible if...** - You are an adult with large B-cell lymphoma (including DLBCL, primary mediastinal large B-cell lymphoma, or high-grade B-cell lymphoma) that: - Did not respond to or came back within 12 months of initial chemoimmunotherapy, OR - Relapsed or is refractory after two or more prior treatment lines - You have at least one measurable lymphoma lesion - At least 2 weeks have passed since your last systemic therapy **You may NOT be eligible if...** - You have active uncontrolled infections - Your heart, liver, kidneys, or lungs are not functioning well enough - You are pregnant or breastfeeding - You have had a prior CAR-T cell therapy - You have active brain involvement from lymphoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmapalumab

An interferon gamma (IFNγ) blocking antibody

DRUGCyclophosphamide

Alkylating agent

DRUGFludarabine Phosphate

Purine antagonist antimetabolite

DRUGAxicabtagene Ciloleucel

Autologous treatment


Locations(2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT06550141


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