Inclusion Criteria:
- Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured
intended for commercial treatment; however, the final manufactured product was
nonconforming and did not meet commercial release criteria
- Remanufacturing is deemed not feasible or clinically inappropriate per assessment of
the treating physician in discussion with the participant
- Clinically stable
Exclusion Criteria:
- Has a hypersensitivity to the active substance or to any of the excipients
- No experience of a significant worsening in clinical status that would, in the opinion
of the treating physician, either increase the risk of Adverse Events associated with
lymphodepleting chemotherapy, or exclude them from treatment with nonconforming
Idecabtagene vicleucel (ide-cel)
- Has any condition and/or laboratory abnormality that places the participant at
unacceptable risk if he/she were to participate in the Expanded Access Protocol based
on the Investigator's judgement
Other protocol-defined inclusion/exclusion criteria apply
