Details

IRB Study Number 22-298

Status Recruiting

Institute Taussig Cancer Institute

Description

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

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The subject must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable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

Exclusion Criteria

none