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Clinical Trials in the USA / NCT07188558
Recruiting Phase 3

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

NCT07188558 · tracked via the Priya Life Science USA tracker
Sponsor
Lyell Immunopharma, Inc.
Phase
Phase 3
Started
2026-01-12
Last updated
2026-08-04

Condition(s) studied

Large B-cell LymphomaLymphoma, B-CellRelapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaNon-Hodgkin LymphomaNon-Hodgkin Lymphoma Refractory/ RelapsedDiffuse Large B Cell Lymphoma (DLBCL)Diffuse Large B Cell Lymphoma RefractoryDiffuse Large B Cell Lymphoma Relapsed

Investigational drug(s) / intervention(s)

rondecabtagene autoleucelaxicabtagene ciloleucellisocabtagene maraleucel

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
Honor Health Scottsdale Arizona Recruiting
Mayo Clinic Arizona Scottsdale Arizona Recruiting
University of Arkansas Little Rock Arkansas Not Yet Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
University of California, Los Angeles (UCLA) Los Angeles California Recruiting
University of California, Irvine Orange California Recruiting
University of Colorado Aurora Colorado Recruiting
Colorado Blood Cancer Institute Denver Colorado Recruiting
MedStar Georgetown University Hospital Washington D.C. District of Columbia Not Yet Recruiting
Mayo Clinic Florida Jacksonville Florida Recruiting
AdventHealth Orlando Florida Not Yet Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Northside Hospital Atlanta Georgia Recruiting
Northwestern Chicago Illinois Not Yet Recruiting
University of Chicago Chicago Illinois Recruiting
University of Iowa Iowa City Iowa Not Yet Recruiting
University of Kansas Cancer Center Westwood Kansas Recruiting
University of Louisville Health Louisville Kentucky Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
University of Nebraska Medical Center (UNMC) Omaha Nebraska Recruiting
Hackensack Hackensack New Jersey Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York Recruiting
Duke Cancer Institute Durham North Carolina Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem North Carolina Not Yet Recruiting
Oncology Hematology Care Clinical Trials Cincinnati Ohio Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
Cleveland Clinical Taussig Cancer Center Cleveland Ohio Not Yet Recruiting
Allegheny Health Network Pittsburgh Pennsylvania Not Yet Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
St. David's South Austin Medical Center Austin Texas Recruiting
University of Texas Southwestern Medical Center Fort Worth Texas Not Yet Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Texas Transplant Institute San Antonio Texas Recruiting
Intermountain Healthcare Salt Lake City Utah Recruiting
Virginia Oncology Associates Norfolk Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07188558 on ClinicalTrials.gov ↗ ← All trials in the USA