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
- Melbourne, Nedlands, and Perth, AustraliaSee the 3 sites
- Phase
- Phase 1/2
Where in Australia
- The Alfred HospitalMelbourne, AustraliaTaking people
- Sir Charles Gairdner HospitalNedlands, AustraliaTaking people
- Royal Perth HospitalPerth, AustraliaTaking 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.