Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma
Sponsor: Kite, A Gilead Company
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
KITE-197
A single infusion of CAR-transduced autologous T cells administered intravenously
Cyclophosphamide
Lymphodepleting chemotherapy administered intravenously
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