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Clinical Trials in the USA / NCT05826535
Recruiting Phase 1/2

Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma

NCT05826535 · tracked via the Priya Life Science USA tracker
Sponsor
Lyell Immunopharma, Inc.
Phase
Phase 1/2
Started
2023-05-09
Last updated
2026-08-25

Condition(s) studied

Relapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaNon-Hodgkin LymphomaLarge B-cell Lymphoma

Investigational drug(s) / intervention(s)

Rondecabtagene autoleucel (ronde-cel)FludarabineCyclophosphamide

Rondecabtagene autoleucel (ronde-cel): CAR T-cell therapy

Fludarabine: Conditioning chemotherapy

Cyclophosphamide: Conditioning chemotherapy

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
University of California-Irvine Medical Center Irvine California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
University of California, Los Angeles (UCLA) Medical Center Los Angeles California Recruiting
Scripps Clinic San Diego California Recruiting
Colorado Blood Cancer Institute Denver Colorado Recruiting
Medstar Georgetown University Hospital Washington D.C. District of Columbia Recruiting
Augusta University Medical Center Augusta Georgia Recruiting
Indiana Blood and Marrow Transplantation Indianapolis Indiana Recruiting
University of Iowa Iowa City Iowa Recruiting
University of Louisville Brown Cancer Center Louisville Kentucky Recruiting
Louisiana State University Health Sciences Center Shreveport Louisiana Recruiting
Corewell Health Grand Rapids Michigan Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
John Theurer Cancer Center Hackensack University Medical Center Hackensack New Jersey Recruiting
University of New Mexico Comprehensive Cancer Center Albuquerque New Mexico Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center New York New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Atrium Health Wake Forest Baptist Winston-Salem North Carolina Recruiting
University of Cincinnati (UC) Physicians Company, LLC Cincinnati Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Lehigh Valley Topper Cancer Center Institute Allentown Pennsylvania Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
West Penn Hospital Pittsburgh Pennsylvania Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Baylor University Medical Center Dallas Texas Recruiting
Texas Transplant Institute San Antonio Texas Recruiting
Huntsman Cancer Institute Salt Lake City Utah Recruiting
Intermountain Healthcare Salt Lake City Utah Recruiting
Virginia Oncology Associates Norfolk Virginia Recruiting
Virginia Commonwealth University-Massey Cancer Center Richmond Virginia Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Sir Charles Gairdner Hospital Nedlands Western Australia Recruiting
Royal Perth Hospital Perth Western Australia Recruiting
The Alfred Hospital Melbourne Australia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05826535 on ClinicalTrials.gov ↗ ← All trials in the USA