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A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
Sponsor: Lyell Immunopharma, Inc.
Summary
This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.
Official title: A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-01-12
Completion Date
2032-01
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
rondecabtagene autoleucel
An autologous, dual-targeting CD19/20 CAR T-cell candidate.
axicabtagene ciloleucel
An autologous CD19 CAR T-cell therapy
lisocabtagene maraleucel
An autologous CD19 CAR T-cell therapy
Locations (39)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Honor Health
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of Arkansas
Little Rock, Arkansas, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
University of Colorado
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
AdventHealth
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Northwestern
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
University of Louisville Health
Louisville, Kentucky, United States
Corewell Health
Grand Rapids, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Nebraska Medical Center (UNMC)
Omaha, Nebraska, United States
Hackensack
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinical Taussig Cancer Center
Cleveland, Ohio, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
University of Texas Southwestern Medical Center
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States