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

NCT07188558 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-03-04

No results posted yet for this 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.

Conditions

  • 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

Interventions

BIOLOGICAL

rondecabtagene autoleucel

An autologous, dual-targeting CD19/20 CAR T-cell candidate.

BIOLOGICAL

axicabtagene ciloleucel

An autologous CD19 CAR T-cell therapy

BIOLOGICAL

lisocabtagene maraleucel

An autologous CD19 CAR T-cell therapy

Sponsors & Collaborators

  • Lyell Immunopharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2029-12-31
Completion
2032-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188558 on ClinicalTrials.gov