Actively Recruiting
Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma
Led by Lyell Immunopharma, Inc. · Updated on 2026-05-07
270
Participants Needed
32
Research Sites
424 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willing and able to provide written informed consent
- Histologically confirmed large B-cell lymphoma as defined by WHO 2022 or International Consensus Classification 2022
- Received at least two prior lines of therapy for Cohorts 1, 2, and 4; at least one prior line for Cohort 3
- Relapsed or refractory disease
- At least one measurable lesion according to Lugano classification
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; or 0 to 2 for Cohort 5
- Absolute neutrophil count (ANC) of 1000/µL or higher
- Platelet count of 50,000/µL or higher
- Absolute lymphocyte count (ALC) of 200/µL or higher
- Other protocol-defined criteria apply
You will not qualify if you...
- 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)-positive 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 except for specific CD19-targeting CAR T therapies in Cohort 2
- Primary immunodeficiency
- History of autoimmune disease causing end organ injury or requiring recent therapy
- Other protocol-defined criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
University of California-Irvine Medical Center
Irvine, California, United States, 92697
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
University of California, Los Angeles (UCLA) Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
4
Scripps Clinic
San Diego, California, United States, 92037
Actively Recruiting
5
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
6
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Actively Recruiting
7
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States, 46237
Actively Recruiting
8
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
9
University of Louisville Brown Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
10
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71130
Actively Recruiting
11
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
12
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
13
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
14
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
15
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
16
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
17
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
18
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
19
University of Cincinnati (UC) Physicians Company, LLC
Cincinnati, Ohio, United States, 45267
Actively Recruiting
20
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
21
Lehigh Valley Topper Cancer Center Institute
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
22
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
23
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
24
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
25
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
26
Texas Transplant Institute
San Antonio, Texas, United States, 78229
Actively Recruiting
27
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
28
Intermountain Healthcare
Salt Lake City, Utah, United States, 84143
Actively Recruiting
29
Virginia Oncology Associates
Norfolk, Virginia, United States, 24502
Actively Recruiting
30
Virginia Commonwealth University-Massey Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
31
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
32
The Alfred Hospital
Melbourne, Australia, 3004
Actively Recruiting
Research Team
S
Stephen Simko, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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