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

Conditions

To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART.

Experimental: Emapalumab
To be eligible to take part in this research study, you will be assigned to 1 of 2 dose levels of emapalumab, based on when you enroll on the study. Up to 2 planned doses will be studied at this time, with about 16-32 total participants enrolled at all dose levels. More dose levels may be studied, if needed. * If at least 3 of the first 5 participants show improvement in their blood test results, 11 more participants will be enrolled at that dose level. * If at least 9 of the first 16 participants enrolled show improvement, that dose will be considered effective. * If fewer than 3 of the first 5 participants show improvement in their blood test results, the study team will move to a higher dose of the drug and repeat the same approach. * Even if a dose level is claimed to be effective, the study team may still choose to test a next higher dose level. If the next higher dose level is tested, enrollment at that dose level will follow the same pattern as the first dose level.

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Facility	City	State	ZIP	Site coordinators
MD Anderson Cancer Center	Houston	Texas	77030	Paolo Strati, MD [email protected] 713-745-1776 Paolo Strati, MD (PRINCIPAL_INVESTIGATOR)

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