Expanded Access Program (EAP) for Obecabtagene-Autoleucel (Obe-Cel) Out-Of-Specification (OOS) in Adult Patients with Acute Lymphoblastic Leukemia - AUTO1-OS1

Brief description of study

The purpose of this program is to provide access to obe-cel treatment for adult patients with ALL who have undergone leukapheresis and had obe-cel manufactured from their blood cells but the product is deemed OOS (does not meet the specifications to be used commercially). The target patients for this study have limited options for treatment and repeat blood sampling is not feasible. The main aims of this study are (1) to provide adult patients with ALL with access to obe-cel and (2) to describe the safety profile of obe-cel (including CRS, ICANS, serious infections, secondary cancers, and any side effects) within the first 45 days after infusion of OOS obe-cel. This study is a single-arm, open-label, multicenter expanded access program (EAP). The patient population included in this EAP will be adult patients diagnosed with recurring or refractory ALL who were prescribed obe-cel as part of their standard of care and are eligible for use under the approved local prescribing information.


Clinical Study Identifier: s25-00561
ClinicalTrials.gov Identifier: NCT06799221
Principal Investigator: Mohammad Maher Abdul Hay.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Nicole Karich, Rena Kandinova, Mihir A Shukla, Jamie M Pavlonnis, Michelle Sun, Marissa Hornacek, Maureen Elizabeth Johnson, Rafael C Singson, Amanda Marie Ferris, Oscar B Lahoud, Jingmei Hsu, Kenny Tai, Eileen Zhao, Jacqueline L Ortiz, Jun Han Choi, Kelsey Stocker, Sejal Singh, Laura P. Diaz, Kristen Randolph Jordan, Jamie Robin Nemrow, Chelsea F Curione, Nora Chokr, Elizabeth Catherine Garace.


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