Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the participant has previously received an infusion of gene-modified cells in a completed Kite-sponsored study and has completed the necessary follow-up assessments in that study.

The participant must sign an informed consent form, indicating understanding and agreement to participate in the study.

Participants who have previously received gene-modified cells, such as brexucabtagene autoleucel or axicabtagene ciloleucel, will continue to be monitored. These treatments are administered as an intravenous infusion, which involves delivering the medication directly into the bloodstream through a vein.

Participants will attend regular follow-up visits to monitor their health and any potential side effects. These visits are crucial for evaluating the incidence and severity of any late-onset adverse effects, which may include neurological, autoimmune, or hematological disorders, serious infections, or secondary malignancies.

During these visits, assessments will be made regarding the participant’s growth, development, and sexual maturity, particularly for pediatric and adolescent participants.

Throughout the study, data will be collected on various health parameters, including the occurrence of any adverse effects, the participant’s survival status, and any subsequent anti-cancer therapies received.

The study aims to understand the mechanisms of any adverse effects related to the gene-modified cell therapy, such as insertional mutagenesis, and to assess immune system recovery.

The study is expected to continue until September 2038. Participants will be monitored throughout this period to gather comprehensive data on the long-term effects of the gene-modified cell therapy.