Study on Emapalumab to Prevent Side Effects from CAR-T Cell Therapy in Non-Hodgkin's Lymphoma Patients

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

Sponsor score: 0

ClinicalTrials ID:NCT06550141

Provider View

This clinical trial is testing whether the drug emapalumab can help prevent a common side effect called cytokine release syndrome in patients with Non-Hodgkin's Lymphoma who are receiving CAR-T cell therapy.

Patient Parameters

Program Overview

The study aims to see if emapalumab can prevent side effects in patients with Non-Hodgkin's Lymphoma (NHL) who are undergoing CAR-T cell therapy. Participants will receive chemotherapy drugs fludarabine and cyclophosphamide, the CAR-T cell therapy axicabtagene ciloleucel, and emapalumab. The study will follow participants for up to 24 months to monitor their health and the effectiveness of the treatment.

Description

This is a Phase 2 study conducted at multiple centers to evaluate the safety and effectiveness of emapalumab in preventing side effects from CAR-T cell therapy in patients with large B-cell Non-Hodgkin's Lymphoma. Phase 2 trials test whether a new treatment is safe and works for a specific disease. Emapalumab is not yet approved by the FDA for this specific use, but it is approved for other conditions. Axicabtagene ciloleucel is already approved for this type of cancer. The study involves several steps, including checking if participants are eligible, collecting T cells, giving chemotherapy, and then administering emapalumab and axicabtagene ciloleucel. Participants will be monitored for up to 24 months after treatment. About 28 people are expected to join this study.

Eligibility Criteria

Inclusion Criteria

  • Adults with large B-cell lymphoma that hasn't responded to initial treatment or has returned within 12 months.
  • Adults with relapsed or refractory large B-cell lymphoma after two or more treatments.
  • At least one measurable tumor at the time of screening.
  • Must wait a certain period after previous treatments before starting the study.
  • Age 18 or older.
  • Good overall health with a performance status score of 0 to 2.
  • Adequate kidney, liver, lung, and heart function based on specific medical tests.
  • Women of childbearing age must have a negative pregnancy test and agree to use birth control.
  • Must understand and agree to sign a consent form.

Exclusion Criteria

  • History of other cancers unless disease-free for at least 3 years.
  • History of certain blood cancers or stem cell transplants.
  • Uncontrolled infections or certain viral infections.
  • Active central nervous system disease or certain brain disorders.
  • Recent heart problems or blood clots.
  • Medical conditions that could interfere with the study.
  • Allergies to study drugs.
  • Pregnant or breastfeeding women, or those not willing to use birth control.
  • Likely inability to complete study visits or follow study requirements.
  • History of autoimmune disease needing ongoing treatment.
  • Recent vaccines or investigational treatments for this condition.

Locations

FACILITYZIPCITYSTATE
Massachusetts General Hospital02114BostonMassachusetts
Dana-Farber Cancer Institute02215BostonMassachusetts

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