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

270 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

34
Australia
Royal Perth Hospital6000, PerthWestern Australia, Australia
The Alfred Hospital3004, Melbourne Australia
United States
California
University of California-Irvine Medical Center92697, Irvine United States
Cedars-Sinai Medical Center90048, Los Angeles United States

Sponsors and collaborators

Lyell Immunopharma, Inc.

Lead sponsor