Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma

Relapsed/Refractory Large B-cell Lymphoma Clinical Trial

Official title: A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma

Status Active, not recruiting

Clinical Trial Summary

This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). The goal of Phase 1b of this clinical study is learn about the effectiveness of the recommended dose of KITE-197 in participants with r/r LBCL.

The primary objectives of this study are:

Phase 1a: To evaluate the safety of KITE-197 in participants with r/r LBCL and determine the target dose level for Phase 1b.

Phase 1b: To evaluate the efficacy of KITE-197 in participants with r/r LBCL as measured by the complete remission (CR) rate.

Clinical Trial Description

Participants will be followed for approximately 24 months after the infusion of KITE-197 before transitioning to a separate Kite long-term follow-up study KT-US-982-5968, in which they will be followed for the remainder of the 15-year follow-up period. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Relapsed/Refractory Large B-cell Lymphoma

• NCT number: NCT06079164
• Study type: Interventional
• Source: Gilead Sciences
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 9, 2023
• Completion date: December 2027