NCT07479797

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed or Refractory Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	KITE-753	A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
DRUG	Axicabtagene Ciloleucel	A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
DRUG	Fludarabine	Administered intravenously
DRUG	Cyclophosphamide	Administered intravenously

Timeline

• Start date: 2026-08-01
• Primary completion: 2031-05-01
• Completion: 2031-05-01
• First posted: 2026-03-18
• Last updated: 2026-04-01

Regulatory

• FDA-regulated drug study