Compares ronde-cel with standard CD19 CAR T-cell therapy in large B-cell lymphoma
Compares ronde-cel with standard CD19 CAR T-cell therapy in adults with lymphoma.
Plain-language title generated from the registry record
Registry title: A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
Key facts
- Where
- Albuquerque, Atlanta, Aurora, Austin, Boston, Buffalo, Chicago, Cincinnati, Cleveland, Denver, Durham, Fort Worth, Gilbert, Hackensack, Houston, Iowa City, Jacksonville, Little Rock, Los Angeles, Louisville, Milwaukee, Morristown, Nashville, Norfolk, Omaha, Orange, Orlando, Pittsburgh, Richmond, Rochester, Salt Lake City, San Antonio, Scottsdale, Tampa, Washington D.C., Westwood, and Winston-Salem, United StatesSee the 41 sites
- Phase
- Phase 3
Where in United States
- University of New Mexico Comprehensive Cancer CenterAlbuquerque, United StatesTaking people
- Northside HospitalAtlanta, United StatesTaking people
- University of ColoradoAurora, United StatesTaking people
- St. David's South Austin Medical CenterAustin, United StatesTaking people
- Tufts Medical CenterBoston, United StatesTaking people
- Roswell Park Comprehensive Cancer CenterBuffalo, United StatesTaking people
- NorthwesternChicago, United StatesTaking people
- University of ChicagoChicago, United StatesTaking people
- Oncology Hematology Care Clinical TrialsCincinnati, United StatesTaking people
- University of CincinnatiCincinnati, United StatesTaking people
- Cleveland Clinical Taussig Cancer CenterCleveland, United StatesTaking people
- Colorado Blood Cancer InstituteDenver, United StatesTaking people
- Duke Cancer InstituteDurham, United StatesTaking people
- University of Texas Southwestern Medical CenterFort Worth, United StatesTaking people
- Banner MD Anderson Cancer CenterGilbert, United StatesTaking people
- HackensackHackensack, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- University of IowaIowa City, United StatesTaking people
- Mayo Clinic FloridaJacksonville, United StatesTaking people
- University of ArkansasLittle Rock, United StatesNot yet recruiting
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- University of California Los Angeles (UCLA).Los Angeles, United StatesTaking people
- University of Louisville HealthLouisville, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- Atlantic HealthMorristown, United StatesTaking people
- SCRI Oncology PartnersNashville, United StatesTaking people
- Virginia Oncology AssociatesNorfolk, United StatesTaking people
- University of Nebraska Medical Center (UNMC)Omaha, United StatesTaking people
- University of California IrvineOrange, United StatesTaking people
- AdventHealthOrlando, United StatesTaking people
- Allegheny Health NetworkPittsburgh, United StatesNot yet recruiting
- Virginia Commonwealth University/Massey Cancer CenterRichmond, United StatesTaking people
- Mayo Clinic - RochesterRochester, United StatesTaking people
- Intermountain HealthcareSalt Lake City, United StatesTaking people
- Texas Transplant InstituteSan Antonio, United StatesTaking people
- Honor HealthScottsdale, United StatesTaking people
- Mayo Clinic - ArizonaScottsdale, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
- MedStar Georgetown University HospitalWashington D.C., United StatesTaking people
- University of Kansas Cancer CenterWestwood, United StatesTaking people
- Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lyell Immunopharma, Inc.
- Trial code
- NCT07188558
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting
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.
Inclusion: CAR T cell naïve and eligible to receive a CD19 CART-cell therapy; 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); Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy; Measurable disease by presence of [18F]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria; Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; Adequate hematological, renal, hepatic, pulmonary, and cardiac function.
Exclusion: Patients ineligible to receive CD19 CAR T-cell therapy; Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment; Active autoimmune disease requiring ongoing systemic immunosuppressive therapy; Note: Other protocol defined Inclusion/Exclusion criteria may apply; 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; Primary CNS lymphoma; 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).