Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma

Recruiting now · Phase 1/Phase 2

Conditions studied: Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Large B-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT05826535

Run by

Lyell Immunopharma, Inc.

People needed

270

Starts

2023-05-09

Expected to finish

2031-06-30

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Willing and able to provide written informed consent
• Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022)
• Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3
• Relapsed or refractory disease.
• At least 1 measurable lesion (per Lugano classification)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)
• Absolute neutrophil count (ANC) ≥ 1000/µL
• Platelet count ≥ 50,000/µL
• Absolute lymphocyte count (ALC) ≥ 200/µL
• Other protocol-defined criteria apply.

You may not qualify if…

• History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years
• Active central nervous system involvement
• History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
• Ongoing or impending oncologic emergency
• Recent systemic anti-cancer therapy or radiation
• Ongoing non-hematologic toxicities due to prior therapy
• History of allogeneic stem cell or solid organ transplantation
• Autologous stem cell transplantation within 6 weeks
• History of prior genetically modified cell therapy (Cohorts 1, 3, 4, 5) or no other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel) (Cohort 2).
• Primary immunodeficiency
• History of autoimmune disease resulting in end organ injury or requiring recent therapy
• Other protocol-defined criteria apply.

Where it is running

• University of California-Irvine Medical Center — Irvine, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• University of California, Los Angeles (UCLA) Medical Center — Los Angeles, California, United States (enrolling)
• Scripps Clinic — San Diego, California, United States (enrolling)
• Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Augusta University Medical Center — Augusta, Georgia, United States (enrolling)
• Indiana Blood and Marrow Transplantation — Indianapolis, Indiana, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• University of Louisville Brown Cancer Center — Louisville, Kentucky, United States (enrolling)
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States (enrolling)
• Corewell Health — Grand Rapids, Michigan, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• John Theurer Cancer Center Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States (enrolling)
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (enrolling)
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (enrolling)
• University of Cincinnati (UC) Physicians Company, LLC — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Lehigh Valley Topper Cancer Center Institute — Allentown, Pennsylvania, United States (enrolling)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
• West Penn Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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