Trial Search Results
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
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
Stanford is currently accepting patients for this trial.
Lead Sponsor:
Kite, A Gilead Company
Stanford Investigator(s):
Intervention(s):
- Biological: Axicabtagene Ciloleucel
- Biological: Brexucabtagene Autoleucel
- Biological: KITE-585
- Biological: KITE-718
- Biological: KITE-439
- Biological: KITE-222
- Biological: KITE-363
Phase:
Phase 2
Eligibility
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Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or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
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kelly Chyan
650-625-8130
Recruiting