OncRef

Clinical Trial: NCT06079164

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Kite, A Gilead Company
Information Provided By:Gilead Sciences
Last Update Posted:2026-08-25

Study Overview

Brief 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.

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

Conditions

Relapsed/Refractory Large B-cell Lymphoma

Intervention / Treatment

  • Drug: KITE-197
  • Drug: Cyclophosphamide
  • Drug: Fludarabine

Other Study ID Numbers

  • KT-US-656-0601

Start Date (Actual)

2023-11-09

Primary Completion Date (Estimated)

2026-11

Study Completion Date (Estimated)

2026-11

Enrollment (Actual)

21

Study Type

Interventional

Phase

Phase 1