IRB Study Number 22-298
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objective
Evaluate the incidence and severity of late-onset targeted AEs/serious AEs (SAEs) suspected to be possibly related to gene-modified cells, including neurological disorders, autoimmune disorders, hematological disorders, serious infections, and secondary malignancies
Evaluate mechanism of 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 cells in the completed parent study
Determine survival status
Determine cause of death
Evaluate immune reconstitution
Evaluate the incidence of RCR/RCL
Exploratory Objectives
Evaluate the levels of genetically-modified cells in blood
Determine the status of the primary malignant disease
Evaluate pregnancy outcomes in females of childbearing potential
Inclusion Criteria
1) The subject must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable
2) The subject must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
3) In the investigator’s judgment, the subject is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation
Exclusion Criteria
none