Expanded Access Program (EAP) for Obecabtagene Autoleucel (obe-cel) Out-of-specification (OOS) in Adult Patients with Acute Lymphoblastic Leukemia
Categories (click each to see list of all clinical trials associated with that category): Cellular Therapy Support Service - CAR-T (ONC), Leukemia/MDS/MPD (ONC)
Current Status: Not open
Phase: N/A (Cancer Control)
Principal Investigator: Gundabolu, Krishna
Contact Information:
Sarah Snook
sarah.snook@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06799221?term=NCT06799221&rank=1
Summary
1. To provide adult patients with r/r B-cell ALL with access to OOS obe-cel that is acceptable per joint assessment by Autolus and physician taking into account Autolus' release criteria.
2. To describe the safety profile of obe-cel (including CRS, ICANS, serious infections, secondary malignancies, and other adverse events [AEs]) within the first 45 days post-first infusion of OOS obe-cel. Development of secondary malignancy is defined as the development of any new malignancy, occurring after the administration of obe-cel.