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   Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or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