Phase 3Recruiting
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
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
- Sponsor
- Kite, A Gilead Company (Industry)
- Enrolment
- 550 planned
- Conditions
- Relapsed or Refractory Large B-cell Lymphoma
- Interventions
- KITE-753; Axicabtagene Ciloleucel; Fludarabine; Cyclophosphamide
- Ages
- adults, older adults
- Registry
- NCT07479797, CTIS2025-524403-80-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Proportion of Participants in Complete Response (CR) at Month 6
- Event-free survival (EFS)
History
Primary completion expected
Last registry update
Started
Registered