RecruitingPhase 1Phase 2NCT05826535

Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of Rondecabtagene Autoleucel, a CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cell Therapy in Participants With Aggressive B-Cell Non-Hodgkin Lymphoma

Sponsor

Lyell Immunopharma, Inc.

Enrollment

270 participants

Start Date

May 9, 2023

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma Large B-cell Lymphoma Relapsed Non Hodgkin Lymphoma

Summary

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of rondecabtagene autoleucel (ronde-cel) also known as LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new treatment called LYL314 — a therapy that redirects your own immune cells to attack cancer — for people with aggressive large B-cell lymphoma (a fast-growing type of blood cancer) that has come back or stopped responding to other treatments. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with a specific type of aggressive large B-cell lymphoma (including DLBCL, transformed follicular lymphoma, PMBCL, or high-grade B-cell lymphoma) - Your cancer has come back or is not responding to treatment after at least 1–2 prior lines of therapy (depending on the group) - You have received prior treatment with an anti-CD20 antibody (like rituximab) and an anthracycline-containing chemotherapy - You have at least one measurable area of cancer visible on scans - Your overall health and organ function meet the study requirements **You may NOT be eligible if...** - Your cancer has been completely eliminated by prior therapy (you must have active disease) - You have another active cancer - Your heart, liver, or kidney function is significantly impaired 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

DRUGRondecabtagene autoleucel (ronde-cel)

CAR T-cell therapy

DRUGFludarabine

Conditioning chemotherapy

DRUGCyclophosphamide

Conditioning chemotherapy

Locations(34)

University of California-Irvine Medical Center

Irvine, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, Los Angeles (UCLA) Medical Center

Los Angeles, California, United States

Scripps Clinic

San Diego, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Indiana Blood and Marrow Transplantation

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

University of Louisville Brown Cancer Center

Louisville, Kentucky, United States

Louisiana State University Health Sciences Center

Shreveport, Louisiana, United States

Corewell Health

Grand Rapids, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

University of Cincinnati (UC) Physicians Company, LLC

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Lehigh Valley Topper Cancer Center Institute

Allentown, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

West Penn Hospital

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

Texas Transplant Institute

San Antonio, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Intermountain Healthcare

Salt Lake City, Utah, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Virginia Commonwealth University-Massey Cancer Center

Richmond, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Royal Perth Hospital

Perth, Western Australia, Australia

The Alfred Hospital

Melbourne, Australia

View Full Details on ClinicalTrials.gov

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NCT05826535

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