A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
NCT ID: NCT07188558
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2026-01-31
2032-01-31
Brief Summary
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Detailed Description
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Patients will be randomized (1:1) before leukapheresis to receive either:
* Ronde-cel; or
* Investigator's choice of axi-cel or liso-cel
Most patients who receive currently approved CD19-directed CAR T-cell therapies, including axi-cel and liso-cel, still experience progressive disease, often due to mechanisms such as CD19 antigen loss or T-cell exhaustion.
Ronde-cel is a novel, autologous, dual-targeting CD19/CD20 CAR T-cell product candidate enriched for CD62L-positive naïve and central memory T cells, which are associated with enhanced proliferation capacity and persistence. Ronde-cel is an "OR"-gated CAR construct that can fully activate upon recognition of either CD19 or CD20, aiming to improve durability of response despite antigen heterogeneity.
Approximately 400 participants will be enrolled. CAR T-cell therapy in both arms will be administered as a single intravenous infusion following fludarabine and cyclophosphamide lymphodepletion. Participants will be followed for 3 years for safety and efficacy, with long-term follow-up extending to 15 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rondecabtagene autoleucel
rondecabtagene autoleucel
An autologous, dual-targeting CD19/20 CAR T-cell candidate.
Investigator's Choice CD19
axicabtagene ciloleucel, lisocabtagene maraleucel
axicabtagene ciloleucel
An autologous CD19 CAR T-cell therapy
lisocabtagene maraleucel
An autologous CD19 CAR T-cell therapy
Interventions
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rondecabtagene autoleucel
An autologous, dual-targeting CD19/20 CAR T-cell candidate.
axicabtagene ciloleucel
An autologous CD19 CAR T-cell therapy
lisocabtagene maraleucel
An autologous CD19 CAR T-cell therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)
* Diffuse large B-cell lymphoma (DLBCL)
* Transformations of indolent B-cell lymphomas (excluding Richter's transformation)
* DLBCL/High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements
* High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)
* Primary mediastinal large B-cell lymphoma (PMBCL)
* Grade 3B follicular lymphoma/large cell follicular lymphoma (FL3B)
3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy
4. Measurable disease by presence of \[18F\]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function
Exclusion Criteria
2. Primary CNS lymphoma
3. Patients with primary cutaneous LBCL, 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)
4. Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years
5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment
6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy.
18 Years
ALL
No
Sponsors
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Lyell Immunopharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Honor Health
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of Arkansas
Little Rock, Arkansas, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
University of Colorado
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
AdventHealth
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Northwestern
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
University of Louisville Health
Louisville, Kentucky, United States
Corewell Health
Grand Rapids, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Nebraska Medical Center (UNMC)
Omaha, Nebraska, United States
Hackensack
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinical Taussig Cancer Center
Cleveland, Ohio, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
University of Texas Southwestern Medical Center
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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LYL314-102
Identifier Type: -
Identifier Source: org_study_id
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