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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma

Sponsor: Lyell Immunopharma, Inc. • ClinicalTrials.gov ID: NCT05826535

Registry updated: 2026-08-25
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Description

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.

Interventions

  • Rondecabtagene autoleucel (ronde-cel) (Drug)
    CAR T-cell therapy
  • Fludarabine (Drug)
    Conditioning chemotherapy
  • Cyclophosphamide (Drug)
    Conditioning chemotherapy

Eligibility criteria

Inclusion Criteria: 1. Age 18 years or older 2. Willing and able to provide written informed consent 3. Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022) 4. Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3 5. Relapsed or refractory disease. 6. At least 1 measurable lesion (per Lugano classification) 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5) 8. Absolute neutrophil count (ANC) ≥ 1000/µL 9. Platelet count ≥ 50,000/µL 10. Absolute lymphocyte count (ALC) ≥ 200/µL Other protocol-defined criteria apply. Exclusion Criteria: 1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years 2. Active central nervous system involvement 3. History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma 4. Ongoing or impending oncologic emergency 5. Recent systemic anti-cancer therapy or radiation 6. Ongoing non-hematologic toxicities due to prior therapy 7. History of allogeneic stem cell or solid organ transplantation 8. Autologous stem cell transplantation within 6 weeks 9. 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). 10. Primary immunodeficiency 11. History of autoimmune disease resulting in end organ injury or requiring recent therapy Other protocol-defined criteria apply.

Conditions

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

Locations

  • 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
  • Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
  • Royal Perth Hospital — Perth, Western Australia, Australia
  • The Alfred Hospital — Melbourne, Australia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record