Pilot Study of Emapalumab to Treat Prolonged Severe Cytopenia After CAR T-Cell Therapy in Adults with Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of emapalumab for treating prolonged severe cytopenia in participants with large B-cell lymphoma LBCL who have received CAR T-cell therapy CART. This pilot study aims to assess how well emapalumab works to improve blood cell counts and to monitor its safety and tolerability. Additionally, the study explores biomarkers that may indicate response or resistance to the treatment. Participants will be assigned to one of two dose levels of emapalumab, given by infusion. Up to two planned doses are being studied initially, with about 16 to 32 participants enrolled in total. The dosing approach involves evaluating improvement in blood test results among early participants to decide whether to continue enrollment at a given dose or to increase the dose. Treatment cycles and dose adjustments are based on the participants responses. Throughout the study, participants will undergo tests such as blood counts and bone marrow biopsies before and after each treatment cycle. Researchers will monitor safety by tracking adverse events and other health measures for about one year after treatment. Participants may also have biomarkers assessed to understand the treatments effects better. The study lasts until the primary completion date, with ongoing evaluations to assess safety and efficacy.

A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia