EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING IDECABTAGENE VICLEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE

Brief description of study

This study is an expanded access protocol (EAP), meaning it is testing how effective and safe it would be to use medicine called nonconforming Idecabtagene Vicleucel (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 study 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.


Clinical Study Identifier: s24-01081
ClinicalTrials.gov Identifier: NCT04771078
Principal Investigator: Mohammad Maher Abdul Hay.
Other Investigators: Nicole Karich, Dimitrios Papaioannou, Rena Kandinova, Rafael C Singson, Amanda Marie Ferris, Maureen Elizabeth Johnson, Eileen Zhao, Jamie Robin Nemrow, Jacqueline L Ortiz, Jingmei Hsu, Oscar B Lahoud, Chelsea F Curione, Laura P. Diaz, Kristen Randolph Jordan, Jamie M Pavlonnis, Kelsey Stocker, Sejal Singh, Elizabeth Catherine Garace, Marissa Hornacek.


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