Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma
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.
270 participants
May 9, 2023
INTERVENTIONAL
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
Inclusion Criteria11
- 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 Criteria12
- 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
- Recent systemic anti-cancer therapy or radiation
- Ongoing non-hematologic toxicities due to prior therapy
- History of allogeneic stem cell or solid organ transplantation
- 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).
- Primary immunodeficiency
- History of autoimmune disease resulting in end organ injury or requiring recent therapy
- Other protocol-defined criteria apply.
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Interventions
CAR T-cell therapy
Conditioning chemotherapy
Conditioning chemotherapy
Locations(28)
View Full Details on ClinicalTrials.gov
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NCT05826535