Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Objective:

Primary Objectives:

• Evaluate the incidence and severity of late-onset targeted adverse events (AEs)/serious adverse events (SAEs) suspected to be possibly related to gene-modified cells, including neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and secondary malignancies
• Evaluate mechanism of replication-competent retrovirus/replication-competent lentivirus (RCR/RCL) and/or insertional mutagenesis for confirmed events related to the cell therapy product
• Evaluate the growth, development, and sexual maturity of
  pediatric and adolescent subjects treated with
  gene-modified cells

Secondary Objectives:

• Determine the time to next treatment after administration of gene-modified cell therapy in the completed parent study
• Determine survival status
• Determine cause of death
• Evaluate immune reconstitution
• Evaluate the incidence of RCR/RCL