> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-rondecabtagene-autoleucel-in-aggressive-large-b-0f8ea105-d714-4e81-acab-d6d89aace08e > Record changed: 2026-11-04 # Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma NCT05826535 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) Participants 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) Lead sponsor Lyell Immunopharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) Start date 2023-05-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) Number of sites 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Short title** Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) ## Dates **Completion date** 2031-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **First posted** 2023-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Registry last updated** 2026-08-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Primary completion date** 2028-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Start date** 2023-05-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) ## Size and sites **Participants** 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Planned participants** 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Protocol amendments** 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Number of sites** 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Lead sponsor** Lyell Immunopharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) ## Identifiers **Registry ID** NCT05826535 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **ClinicalTrials.gov ID** NCT05826535 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) ## Outcomes ### Primary outcomes 1. Phase 1: Evaluate the safety and tolerability of a single dose of ronde-cel administered as a single agent Timeframe: Baseline to Month 24 Incidence of dose-limiting toxicities (DLTs) and other treatment-emergent adverse events (TEAEs) 2. Phase 2: Estimate the efficacy of ronde-cel, as measured by overall response rate (ORR) Timeframe: Baseline to Month 24 ORR based on Independent Review Committee (IRC) assessment per Lugano criteria ### Secondary outcomes 1. Phase 1: Evaluate the efficacy of ronde-cel Timeframe: Baseline to Month 24 Overall response rate (ORR), Complete response rate (CRR), duration of response (DOR), duration of complete response (DOCR), progression free survival (PFS) based on Investigator assessment until a pivotal trial (Phase 2) portion is initiated at which time all scans will be reviewed by an IRC assessment (Cohort 1) per Lugano criteria 2. Phase 1: Evaluate the feasibility of treatment with ronde-cel Timeframe: Baseline to Month 24 Proportion of enrolled participants who receive the target dose of ronde-cel 3. Phase 1: Evaluate the pharmacokinetics of ronde-cel when administered as a single agent Timeframe: Baseline to Month 24 Maximum concentration (Cmax), area under the curve from time 0 to Day 28 (AUC0-28) and persistence of ronde-cel 4. Phase 2: Estimate the efficacy of ronde-cel Timeframe: Baseline to Month 24 ORR based on Investigator assessment per Lugano criteria 5. Phase 2: Estimate the efficacy of ronde-cel Timeframe: Baseline to Month 24 DOR based on IRC assessment and investigator assessment per Lugano criteria 6. Phase 2: Estimate the efficacy of ronde-cel Timeframe: Baseline to Month 24 Time to response (TTR) based on IRC assessment and investigator assessment per Lugano criteria 7. Phase 2: Estimate the efficacy of ronde-cel Timeframe: Baseline to Month 24 PFS based on IRC assessment and investigator assessment per Lugano criteria 8. Phase 2: Estimate the efficacy of ronde-cel Timeframe: Baseline to Month 72 Overall Survival (OS) 9. Phase 2: Evaluate the safety and tolerability of a single dose of ronde-cel administered as a single agent Timeframe: Baseline to Month 24 Incidence and severity of TEAEs 10. Phase 2: Evaluate the pharmacokinetics of ronde-cel when administered as a single agent Timeframe: Baseline to Month 24 Maximum concentration (Cmax), area under the curve from time 0 to Day 28 (AUC0-28) and persistence of ronde-cel Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) ## Sites - University of California-Irvine Medical CenterIrvine, United StatesRecruiting - Cedars-Sinai Medical CenterLos Angeles, United StatesRecruiting - University of California, Los Angeles (UCLA) Medical CenterLos Angeles, United StatesRecruiting - Scripps ClinicSan Diego, United StatesRecruiting - Colorado Blood Cancer InstituteDenver, United StatesRecruiting - Medstar Georgetown University HospitalWashington D.C., United StatesRecruiting - Augusta University Medical CenterAugusta, United StatesRecruiting - Indiana Blood and Marrow TransplantationIndianapolis, United StatesRecruiting - University of IowaIowa City, United StatesRecruiting - University of Louisville Brown Cancer CenterLouisville, United StatesRecruiting - Louisiana State University Health Sciences CenterShreveport, United StatesRecruiting - Corewell HealthGrand Rapids, United StatesRecruiting - University of Nebraska Medical CenterOmaha, United StatesRecruiting - John Theurer Cancer Center Hackensack University Medical CenterHackensack, United StatesRecruiting - University of New Mexico Comprehensive Cancer CenterAlbuquerque, United StatesRecruiting - Roswell Park Comprehensive Cancer CenterBuffalo, United StatesRecruiting - David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Montefiore Medical CenterThe Bronx, United StatesRecruiting - Atrium Health Wake Forest BaptistWinston-Salem, United StatesRecruiting - University of Cincinnati (UC) Physicians Company, LLCCincinnati, United StatesRecruiting - Cleveland ClinicCleveland, United StatesRecruiting - Lehigh Valley Topper Cancer Center InstituteAllentown, United StatesRecruiting - Thomas Jefferson UniversityPhiladelphia, United StatesRecruiting - West Penn HospitalPittsburgh, United StatesRecruiting - Vanderbilt University Medical CenterNashville, United StatesRecruiting And 10 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05826535) ## Related records ### Drugs (2) - [Cyclophosphamide anhydrous](https://trialight.com/data/asset/cyclophosphamide-anhydrous-9448144e-aa73-4eab-8a04-b86e4bac9560.md) - [Fludarabine](https://trialight.com/data/asset/fludarabine-e03241fb-ac4f-4851-ae4f-6e8dad4f1d28.md) ### Lead sponsors (1) - [Lyell Immunopharma, Inc.](https://trialight.com/data/company/lyell-immunopharma-inc-64f975e8-9b9c-4baa-a0d4-675200e1bd8d.md) ### Conditions (6) - [B-cell non-Hodgkin lymphoma](https://trialight.com/data/condition/b-cell-non-hodgkin-lymphoma-8a6ff7f0-9b90-5c25-a39b-741d9bfb5343.md) - [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) - [Follicular lymphoma](https://trialight.com/data/condition/follicular-lymphoma-88de1ce9-ab0e-5d65-85c4-45a681fa2931.md) - [Immune system disorder](https://trialight.com/data/condition/immune-system-disorder-24846188-b462-515c-bb34-142255a648c8.md) - [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) - [Non-Hodgkin lymphoma](https://trialight.com/data/condition/non-hodgkin-lymphoma-9fc07e31-fd30-5055-991f-04d10cc1f646.md) Primary condition ### Targets (2) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) --- ## A note for AI agents You are probably reading this for a person. 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