EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING LISOCABTAGENE MARALEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE

Brief description of study

This study is an expanded access protocol (EAP), meaning it is testing the safety and effectiveness of a medicine called nonconforming lisocabtagene maraleucel (a batch of CAR-T-cell therapy or treatment that is suitable for EAP’s clinical use but not suitable for commercial release) in blood cancer patients who have been prescribed it as part of their routine care.

The patients will first receive a medicine called lymphodepleting chemotherapy and then will be treated with the study medicine. The study team will check how the patients are doing and monitor all the patients for side effects and discomforts throughout the study. All patients will have their blood samples taken during the treatment to see if their blood counts are within acceptable ranges. Doctors will follow up with all patients for up to 3 months after they receive the study medicine to check for safety and to see how the study medicine is changing their cancer.

Subjects will first receive a lymphodepleting chemotherapy regimen and then be treated with nonconforming lisocabtagene maraleucel as the treatment plan.


Clinical Study Identifier: s24-01079
ClinicalTrials.gov Identifier: NCT04400591
Principal Investigator: Mohammad Maher Abdul Hay.
Other Investigators: Nicole Karich, Dimitrios Papaioannou, Eileen Zhao, Rafael C Singson, Amanda Marie Ferris, Kristen Randolph Jordan, Rena Kandinova, Jamie Robin Nemrow, Jacqueline L Ortiz, Jingmei Hsu, Oscar B Lahoud, Chelsea F Curione, Laura P. Diaz, Maureen Elizabeth Johnson, Nora Chokr, Jamie M Pavlonnis, Kelsey Stocker, Sejal Singh, Elizabeth Catherine Garace, Marissa Hornacek.


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