A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
Kite, A Gilead Company
Summary
The goal of this clinical study is to compare the study drug KITE-753 versus axicabtagene ciloleucel (axi-cel) in adult participants with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) after one prior line of therapy. The primary objective of this study is to evaluate the efficacy of KITE-753 versus axicabtagene ciloleucel.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Individuals with any of the following large B-cell lymphomas, as determined by the investigator, are eligible for the study as defined below: * World Health Organization (WHO): * Individuals with chemorefractory disease to first-line therapy (primary refractory disease) that satisfies any of the following criteria: * Progressive disease (PD) and/or Deauville score of 5 (irrespective of the response designation) as the best response during the first-line treatment or as the end of treatment response following first-line therapy. * Stable disease (…
Interventions
- DrugKITE-753
A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
- DrugAxicabtagene Ciloleucel
A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
- DrugFludarabine
Administered intravenously
- DrugCyclophosphamide
Administered intravenously
Location
- Stanford UniversityStanford, California