Actively Recruiting
A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
Led by Lyell Immunopharma, Inc. · Updated on 2026-03-04
400
Participants Needed
39
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.
CONDITIONS
Official Title
A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- CAR T cell naive and eligible to receive a CD19 CAR T-cell therapy
- Histologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma, transformations of indolent B-cell lymphomas (excluding Richter's transformation), DLBCL/high-grade B-cell lymphoma with MYC and BCL2 rearrangements, high-grade B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, or grade 3B follicular lymphoma/large cell follicular lymphoma
- Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy
- Measurable disease with a positive lesion on [18F]-fluorodeoxyglucose PET/CT scan during screening according to Lugano Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematological, renal, hepatic, pulmonary, and cardiac function
You will not qualify if you...
- Ineligibility to receive CD19 CAR T-cell therapy
- Primary central nervous system (CNS) lymphoma
- Primary cutaneous large B-cell lymphoma, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter's transformation)
- Prior history of malignancy other than aggressive relapsed or refractory large B-cell lymphoma unless disease-free for at least 2 years
- Uncontrolled systemic fungal, bacterial, viral, or other infections despite treatment
- Active autoimmune disease requiring ongoing systemic immunosuppressive therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Not Yet Recruiting
2
Honor Health
Scottsdale, Arizona, United States, 85258
Not Yet Recruiting
3
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Not Yet Recruiting
4
University of Arkansas
Little Rock, Arkansas, United States, 72205
Not Yet Recruiting
5
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
6
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Not Yet Recruiting
7
University of California, Irvine
Orange, California, United States, 92868
Not Yet Recruiting
8
University of Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
9
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
10
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
11
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
12
AdventHealth
Orlando, Florida, United States, 32804
Not Yet Recruiting
13
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
14
Northside Hospital
Atlanta, Georgia, United States, 30342
Active, Not Recruiting
15
Northwestern
Chicago, Illinois, United States, 60611
Not Yet Recruiting
16
University of Chicago
Chicago, Illinois, United States, 60637
Not Yet Recruiting
17
University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
18
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Not Yet Recruiting
19
University of Kentucky
Lexington, Kentucky, United States, 40536
Not Yet Recruiting
20
University of Louisville Health
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
21
Corewell Health
Grand Rapids, Michigan, United States, 49503
Not Yet Recruiting
22
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
23
University of Nebraska Medical Center (UNMC)
Omaha, Nebraska, United States, 68105
Not Yet Recruiting
24
Hackensack
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
25
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Not Yet Recruiting
26
Duke Cancer Institute
Durham, North Carolina, United States, 27705
Not Yet Recruiting
27
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Not Yet Recruiting
28
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, United States, 45242
Not Yet Recruiting
29
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Not Yet Recruiting
30
Cleveland Clinical Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
31
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Not Yet Recruiting
32
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
33
St. David's South Austin Medical Center
Austin, Texas, United States, 78704
Actively Recruiting
34
University of Texas Southwestern Medical Center
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
35
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
36
Texas Transplant Institute
San Antonio, Texas, United States, 78229
Actively Recruiting
37
Intermountain Healthcare
Salt Lake City, Utah, United States, 84143
Actively Recruiting
38
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
39
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Not Yet Recruiting
Research Team
D
David Shook, MD
CONTACT
M
Mary Lessig, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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