RecruitingPhase 3NCT07188558

A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy

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

Sponsor

Lyell Immunopharma, Inc.

Enrollment

400 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

Lymphoma, B-Cell Large B-cell Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new CAR T-cell therapy called ronde-cel to existing approved CAR T-cell therapies for people with a type of aggressive blood cancer called large B-cell lymphoma that has come back or stopped responding to treatment. **You may be eligible if...** - You have been diagnosed with large B-cell lymphoma (such as DLBCL, high-grade B-cell lymphoma, or primary mediastinal large B-cell lymphoma) - Your cancer has come back or stopped responding after first-line treatment that included chemotherapy and a drug called rituximab - You have never received CAR T-cell therapy before - Your cancer is still detectable on imaging - You are well enough to participate (ECOG 0 or 1) **You may NOT be eligible if...** - You have lymphoma in the brain - You have certain other types of lymphoma (such as Burkitt, Richter's transformation, or T-cell lymphoma) - You have another active cancer (unless cancer-free for 2 or more years) - You have an active, serious infection or autoimmune disease requiring immune-suppressing drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALrondecabtagene autoleucel

An autologous, dual-targeting CD19/20 CAR T-cell candidate.

BIOLOGICALaxicabtagene ciloleucel

An autologous CD19 CAR T-cell therapy

BIOLOGICALlisocabtagene 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

View Full Details on ClinicalTrials.gov

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NCT07188558

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