Tests a cell therapy in adults with aggressive large B-cell lymphoma
Tests rondecabtagene autoleucel, a modified-immune-cell treatment, in adults with aggressive lymphoma.
Plain-language title generated from the registry record
Registry title: Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma
Key facts
- Where
- Albuquerque, Allentown, Augusta, Buffalo, Cincinnati, Cleveland, Dallas, Denver, Grand Rapids, Hackensack, Indianapolis, Iowa City, Irvine, Los Angeles, Louisville, Milwaukee, Nashville, New York, Norfolk, Omaha, Philadelphia, Pittsburgh, Richmond, Salt Lake City, San Antonio, San Diego, Shreveport, The Bronx, Washington D.C., and Winston-Salem, United StatesSee the 32 sites
- Phase
- Phase 1/2
Where in United States
- University of New Mexico Comprehensive Cancer CenterAlbuquerque, United StatesTaking people
- Lehigh Valley Topper Cancer Center InstituteAllentown, United StatesTaking people
- Augusta University Medical CenterAugusta, United StatesTaking people
- Roswell Park Comprehensive Cancer CenterBuffalo, United StatesTaking people
- University of Cincinnati (UC) Physicians Company, LLCCincinnati, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- Baylor University Medical CenterDallas, United StatesTaking people
- Colorado Blood Cancer InstituteDenver, United StatesTaking people
- Corewell HealthGrand Rapids, United StatesTaking people
- John Theurer Cancer Center, Hackensack University Medical CenterHackensack, United StatesTaking people
- Indiana Blood and Marrow TransplantationIndianapolis, United StatesTaking people
- University of IowaIowa City, United StatesTaking people
- University of California, Irvine Medical CenterIrvine, United StatesTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- University of California, Los Angeles (UCLA) - Medical CenterLos Angeles, United StatesTaking people
- University of Louisville Brown Cancer CenterLouisville, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, United StatesTaking people
- Virginia Oncology AssociatesNorfolk, United StatesTaking people
- University of Nebraska Medical CenterOmaha, United StatesTaking people
- Thomas Jefferson UniversityPhiladelphia, United StatesTaking people
- West Penn HospitalPittsburgh, United StatesTaking people
- Virginia Commonwealth University/Massey Cancer CenterRichmond, United StatesTaking people
- Huntsman Cancer InstituteSalt Lake City, United StatesTaking people
- Intermountain HealthcareSalt Lake City, United StatesTaking people
- Texas Transplant InstituteSan Antonio, United StatesTaking people
- Scripps ClinicSan Diego, United StatesTaking people
- Louisiana State University Health Sciences CenterShreveport, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- MedStar Georgetown University HospitalWashington D.C., United StatesTaking people
- Atrium Health Wake Forest BaptistWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lyell Immunopharma, Inc.
- Trial code
- NCT05826535
- Record updated
- 25 August 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Ongoing non-hematologic toxicities due to prior therapy; 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); History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years; History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma; Recent systemic anti-cancer therapy or radiation; History of allogeneic stem cell or solid organ transplantation; History of autoimmune disease resulting in end organ injury or requiring recent therapy; Other protocol-defined criteria apply; Active central nervous system involvement; Ongoing or impending oncologic emergency; Primary immunodeficiency.