Emapalumab Prevention of CAR-T Cell Associated Toxicities

Description

This is a phase 2 multi-center, open label study that is evaluating the safety and efficacy of emapalumab in preventing toxicities associated with axicabtagene ciloleucel in subjects with second- or third-line large B-cell non-Hodgkin’s lymphoma.

A phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. “Investigational” means that the drug is being studied.

The U.S. Food and Drug Administration (FDA) has not approved emapalumab for the participants specific disease, but it has been approved for other uses.

The U.S. FDA has approved axicabtagene ciloleucel for the participants specific disease.

This research study procedures include screening for eligibility, study treatment including collection of T cells (leukapheresis), lymphodepleting chemotherapy, treatment with emapalumab and axicabtagene ciloleucel, and follow-up evaluations.

Once study treatment is completed, the participants will be followed for up to 24 months.

It is expected that about 28 people will take part in this research study.