Study Comparing Ronde-cel to Other CAR T-Cell Therapies for Lymphoma

This study is looking at a new type of CAR T-cell therapy called rondecabtagene autoleucel (ronde-cel) for people with large B-cell lymphoma that has come back or is not responding to treatment. Ronde-cel is a type of immunotherapy that uses your own modified immune cells to fight cancer. It targets two markers on cancer cells, CD19 and CD20. This study will compare ronde-cel to two other approved CAR T-cell therapies, axicabtagene ciloleucel and lisocabtagene maraleucel, which both target CD19. The goal is to see if ronde-cel can help people live longer without their cancer returning. You may be able to join if you are at least 18 years old and have not had CAR T-cell therapy before. The study plans to include about 400 participants.

Study design
This is a Phase 3 randomized controlled trial, meaning participants are randomly assigned to receive either ronde-cel or one of the other two approved CAR T-cell therapies. Approximately 400 participants will be enrolled.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure event-free survival for 36 months after treatment.

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NCT07188558

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Lyell Immunopharma, Inc.
~400 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:rondecabtagene autoleucelaxicabtagene ciloleucellisocabtagene maraleucel

At a glance

Recruiting sites
27 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event free survival
Measured over 36 months
Large B-cell Lymphoma
Lymphoma, B-Cell
Relapsed Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma Refractory/ Relapsed
Diffuse Large B Cell Lymphoma (DLBCL)
Diffuse Large B Cell Lymphoma Refractory
Diffuse Large B Cell Lymphoma Relapsed
36 sites across 22 states
Texas4
Arizona3
California3
Florida3
Ohio3
Colorado2
Illinois2
North Carolina2

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Eligibility criteria

Inclusion

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
  • Event free survival36 months

    The time interval from treatment initiation until the occurrence of a specific event of interest.