This expanded access study is for men and women whose immune cells (T cells) were genetically engineered to create a treatment called brexucabtagene autoleucel, but the genetically engineered cells did not meet the U.S. Food and Drug Administration’s (FDA) approved criteria for release back to the participant for treatment. If the participant’s doctor feels that treatment with the commercially out-of-specification brexucabtagene autoleucel is still the best option, the participant can receive the out-of-specification product through this program.
   
The purpose of this expanded access program is to provide participants with brexucabtagene autoleucel that is otherwise out of specification for commercial release. Participants need to be diagnosed with a disease that the FDA has approved for treatment with brexucabtagene autoleucel.

If they choose to take part, participants will come back to the clinic so that their genetically modified T cells product (brexucabtagene autoleucel) can be given back to them through an intravenous (IV) infusion. The hope is that the genetically modified T cells product can then target and kills tumor cells.

Participation in the program will start at the time of informed consent and last until 30 days after receiving brexucabtagene autoleucel.