Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma (NCT05826535) | Clinical Trial Compass
RecruitingPhase 1/2
Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma
United States270 participantsStarted 2023-05-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
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
2
Phase 2: Estimate the efficacy of ronde-cel, as measured by overall response rate (ORR)