Open Actively Recruiting

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

About

Brief Summary

The primary objectives of this study are to:

- 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

Primary Purpose
Other
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
N/A
Maximum Age
N/A

Inclusion Criteria:

  • The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable
  • The individual 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
  • In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation

Exclusion Criteria: none

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Study Stats
Protocol No.
22-000859
Category
Hematology-Oncology
Oncology
Contact
ANNABEL LIU
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05041309
For detailed technical eligibility, visit ClinicalTrials.gov.