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
Lyell Immunopharma, Inc.
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.
Description
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of ronde-cel, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma. Five cohorts of participants will be enrolled: Cohort 1: (3rd or later line, 3L+) Participants who have received least two prior lines of treatment Cohort 2: (CAR T-cell experienced, 3L+): Participants who have received at least two prior lines of treatment including one prior CAR T. Cohort 3: (second line, 2L) Participants with refract…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugRondecabtagene autoleucel (ronde-cel)
CAR T-cell therapy
- DrugFludarabine
Conditioning chemotherapy
- DrugCyclophosphamide
Conditioning chemotherapy
Locations (32)
- University of California-Irvine Medical CenterIrvine, California
- Cedars-Sinai Medical CenterLos Angeles, California
- University of California, Los Angeles (UCLA) Medical CenterLos Angeles, California
- Scripps ClinicSan Diego, California
- Colorado Blood Cancer InstituteDenver, Colorado
- Augusta University Medical CenterAugusta, Georgia