About this trial
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 criteria
Qualifiers
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
Disqualifiers
History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years
Active central nervous system involvement
History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
Ongoing or impending oncologic emergency
Trial design
Treatments tested in this trial
- Rondecabtagene autoleucel (ronde-cel)
- Fludarabine
- Cyclophosphamide
Treatment groups
6
Treatment groupsSee each treatment group below.