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ACTIVE NOT RECRUITING
NCT06079164
PHASE1

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

Sponsor: Kite, A Gilead Company

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2023-11-09

Completion Date

2026-07

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

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

Locations (11)

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States

St. David's South Austin Medical Center

Austin, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Royal Brisbane and Women's Hospital

South Brisbane, Queensland, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Cross Cancer Institute

Edmonton, Canada

QEII Health Sciences Centre

Halifax, Canada

Jewish General Hospital

Montreal, Canada