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Taking people in United StatesPhase 3

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.

Key facts

Who runs it
Lyell Immunopharma, Inc.
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 sitesAlso in 2 other countries, 3 sites
Trial code
Registry title
A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
Status
Recruiting
Phase
Phase 3
People taking part
400 people, planned
Started
12 Jan 2026
Expected to end
Jan 2032
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • rondecabtagene autoleucel
  • axicabtagene ciloleucel
  • lisocabtagene maraleucel
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with large B-cell lymphoma that came back or did not respond after first treatment, and who have not had CAR T-cell therapy before.

Age
18 years or older
Sex
All sexes can join
Disease stage
Large B-cell lymphoma (including DLBCL and related types) that relapsed or did not respond after first-line chemoimmunotherapy; measurable disease on PET/CT; ECOG performance status 0 or 1
Earlier treatment
Must have had an anti-CD20 antibody and an anthracycline-containing first-line chemoimmunotherapy; must never have had CAR T-cell therapy

Main reasons for not taking part

  • Cannot receive CD19 CAR T-cell therapy
  • Primary CNS lymphoma
  • Primary cutaneous large B-cell lymphoma, Burkitt lymphoma or Richter's transformation
  • Another cancer in the past, unless free of it for 2 years or more
  • Uncontrolled infection or active autoimmune disease needing ongoing immunosuppressive treatment

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in United States

Also in 2 other countries, 3 sites

  • University of New Mexico Comprehensive Cancer CenterAlbuquerque, United StatesContact: James Dean, MD, PhDTaking people
  • Northside HospitalAtlanta, United StatesContact: James Dean, MD, PhDTaking people
  • University of ColoradoAurora, United StatesContact: James Dean, MD, PhDTaking people
  • St. David's South Austin Medical CenterAustin, United StatesContact: James Dean, MD, PhDTaking people
  • Tufts Medical CenterBoston, United StatesContact: James Dean, MD, PhDTaking people
  • Roswell Park Comprehensive Cancer CenterBuffalo, United StatesContact: James Dean, MD, PhDTaking people
  • NorthwesternChicago, United StatesContact: James Dean, MD, PhDTaking people
  • University of ChicagoChicago, United StatesContact: James Dean, MD, PhDTaking people
  • Oncology Hematology Care Clinical TrialsCincinnati, United StatesContact: James Dean, MD, PhDTaking people
  • University of CincinnatiCincinnati, United StatesContact: James Dean, MD, PhDTaking people
  • Cleveland Clinical Taussig Cancer CenterCleveland, United StatesContact: James Dean, MD, PhDTaking people
  • Colorado Blood Cancer InstituteDenver, United StatesContact: James Dean, MD, PhDTaking people
  • Duke Cancer InstituteDurham, United StatesContact: James Dean, MD, PhDTaking people
  • University of Texas Southwestern Medical CenterFort Worth, United StatesContact: James Dean, MD, PhDTaking people
  • Banner MD Anderson Cancer CenterGilbert, United StatesContact: James Dean, MD, PhDTaking people
  • HackensackHackensack, United StatesContact: James Dean, MD, PhDTaking people
  • MD Anderson Cancer CenterHouston, United StatesContact: James Dean, MD, PhDTaking people
  • University of IowaIowa City, United StatesContact: James Dean, MD, PhDTaking people
  • Mayo Clinic FloridaJacksonville, United StatesContact: James Dean, MD, PhDTaking people
  • University of ArkansasLittle Rock, United StatesContact: James Dean, MD, PhDNot yet recruiting
  • Cedars-Sinai Medical CenterLos Angeles, United StatesContact: James Dean, MD, PhDTaking people
  • University of California Los Angeles (UCLA).Los Angeles, United StatesContact: James Dean, MD, PhDTaking people
  • University of Louisville HealthLouisville, United StatesContact: James Dean, MD, PhDTaking people
  • Medical College of WisconsinMilwaukee, United StatesContact: James Dean, MD, PhDTaking people
  • Atlantic HealthMorristown, United StatesContact: James Dean, MD, PhDTaking people
  • SCRI Oncology PartnersNashville, United StatesContact: James Dean, MD, PhDTaking people
  • Virginia Oncology AssociatesNorfolk, United StatesContact: James Dean, MD, PhDTaking people
  • University of Nebraska Medical Center (UNMC)Omaha, United StatesContact: James Dean, MD, PhDTaking people
  • University of California IrvineOrange, United StatesContact: James Dean, MD, PhDTaking people
  • AdventHealthOrlando, United StatesContact: James Dean, MD, PhDTaking people
  • Allegheny Health NetworkPittsburgh, United StatesContact: James Dean, MD, PhDNot yet recruiting
  • Virginia Commonwealth University/Massey Cancer CenterRichmond, United StatesContact: James Dean, MD, PhDTaking people
  • Mayo Clinic - RochesterRochester, United StatesContact: James Dean, MD, PhDTaking people
  • Intermountain HealthcareSalt Lake City, United StatesContact: James Dean, MD, PhDTaking people
  • Texas Transplant InstituteSan Antonio, United StatesContact: James Dean, MD, PhDTaking people
  • Honor HealthScottsdale, United StatesContact: James Dean, MD, PhDTaking people
  • Mayo Clinic - ArizonaScottsdale, United StatesContact: James Dean, MD, PhDTaking people
  • Moffitt Cancer CenterTampa, United StatesContact: James Dean, MD, PhDTaking people
  • MedStar Georgetown University HospitalWashington D.C., United StatesContact: James Dean, MD, PhDTaking people
  • University of Kansas Cancer CenterWestwood, United StatesContact: James Dean, MD, PhDTaking people
  • Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, United StatesContact: James Dean, MD, PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Rondecabtagene autoleucelTreatment being tested
  • Investigator's Choice CD19Existing treatment, for comparison

    axicabtagene ciloleucel, lisocabtagene maraleucel

    Treatment: axicabtagene ciloleucel and lisocabtagene maraleucel

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Compares ronde-cel with standard CD19 CAR T-cell therapy in large B-cell lymphomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 November 2026