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A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Key Inclusion Criteria:

1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy
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

Key Exclusion Criteria:

1. Patients ineligible to receive CD19 CAR T-cell therapy
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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

About the study

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.

What is being tested

Sponsor: Lyell Immunopharma, Inc. · Participants: 400 · Started: Jan 12, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07188558

Locations in the U.S.

ArizonaBanner MD Anderson Cancer Center, Gilbert
Honor Health, Scottsdale
Mayo Clinic Arizona, Scottsdale
ArkansasUniversity of Arkansas, Little Rock (Not yet recruiting)
CaliforniaCedars-Sinai Medical Center, Los Angeles
University of California, Los Angeles (UCLA), Los Angeles
University of California, Irvine, Orange
ColoradoUniversity of Colorado, Aurora
Colorado Blood Cancer Institute, Denver
District of ColumbiaMedStar Georgetown University Hospital, Washington D.C. (Not yet recruiting)
FloridaMayo Clinic Florida, Jacksonville
AdventHealth, Orlando (Not yet recruiting)
Moffitt Cancer Center, Tampa
GeorgiaNorthside Hospital, Atlanta
IllinoisNorthwestern, Chicago (Not yet recruiting)
University of Chicago, Chicago
IowaUniversity of Iowa, Iowa City (Not yet recruiting)
KansasUniversity of Kansas Cancer Center, Westwood
KentuckyUniversity of Louisville Health, Louisville
MinnesotaMayo Clinic Rochester, Rochester
NebraskaUniversity of Nebraska Medical Center (UNMC), Omaha
New JerseyHackensack, Hackensack
New YorkRoswell Park Comprehensive Cancer Center, Buffalo
North CarolinaDuke Cancer Institute, Durham
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem (Not yet recruiting)
OhioOncology Hematology Care Clinical Trials, Cincinnati
University of Cincinnati, Cincinnati
Cleveland Clinical Taussig Cancer Center, Cleveland (Not yet recruiting)
PennsylvaniaAllegheny Health Network, Pittsburgh (Not yet recruiting)
TennesseeSCRI Oncology Partners, Nashville
TexasSt. David's South Austin Medical Center, Austin
University of Texas Southwestern Medical Center, Fort Worth (Not yet recruiting)
MD Anderson Cancer Center, Houston
Texas Transplant Institute, San Antonio
UtahIntermountain Healthcare, Salt Lake City
VirginiaVirginia Oncology Associates, Norfolk

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.