Trials / Active Not Recruiting

Active Not RecruitingNCT06079164

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

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
Phase: Phase 1
Study type: Interventional
Enrollment: 39 (estimated)

Sponsor: Kite, A Gilead Company · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

Participants will be followed for approximately 6 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.

Conditions

Relapsed/Refractory Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	KITE-197	A single infusion of CAR-transduced autologous T cells administered intravenously
DRUG	Cyclophosphamide	Lymphodepleting chemotherapy administered intravenously
DRUG	Fludarabine	Lymphodepleting chemotherapy administered intravenously

Timeline

Start date: 2023-11-09
Primary completion: 2026-07-01
Completion: 2026-07-01
First posted: 2023-10-12
Last updated: 2026-01-08

Locations

11 sites across 3 countries: United States, Australia, Canada

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06079164. Inclusion in this directory is not an endorsement.