Study of Rondecabtagene Autoleucel for Large B-Cell Lymphoma

This study is testing a new type of immunotherapy called rondecabtagene autoleucel (ronde-cel), also known as LYL314, for people with aggressive large B-cell lymphoma (a type of blood cancer). This treatment is a CAR T-cell therapy, which means it uses your own immune cells to fight cancer. Before receiving ronde-cel, you will also receive chemotherapy drugs called fludarabine and cyclophosphamide. The study aims to see how safe ronde-cel is and how well it works to shrink tumors. You may be eligible if you are 18 or older and have received at least one or two prior treatments for your lymphoma, depending on your specific situation. The study plans to enroll about 270 participants, but its current status is unclear.

Study design
This is a Phase 1/2, multi-center, open-label study, meaning both you and your doctors will know what treatment you are receiving. It will enroll up to approximately 150 participants in the first phase to find the right dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for safety and how well the treatment works for up to 24 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05826535

Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Lyell Immunopharma, Inc.
~270 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Rondecabtagene autoleucel (ronde-cel)FludarabineCyclophosphamide

At a glance

Recruiting sites
35 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Evaluate the safety and tolerability of a single dose of ronde-cel administered as a single agent
Measured over Baseline to Month 24
+1 more outcome measured
Relapsed Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Large B-cell Lymphoma
35 sites across 23 states
California4
New York3
Pennsylvania3
Ohio2
Texas2
Utah2
Virginia2
Western Australia2

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  • Phase 1: Evaluate the safety and tolerability of a single dose of ronde-cel administered as a single agentBaseline to Month 24

    Incidence of dose-limiting toxicities (DLTs) and other treatment-emergent adverse events (TEAEs)

  • Phase 2: Estimate the efficacy of ronde-cel, as measured by overall response rate (ORR)Baseline to Month 24

    ORR based on Independent Review Committee (IRC) assessment per Lugano criteria