Clinical Trial

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

Study acronym: PiNACLE-H2H
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-09-16; most recent amendment 2026-06-04.
Status change: Not Yet Recruiting → Recruiting 2025-12-02
Trial Details
NCT Number NCT07188558
Lead Sponsor Lyell Immunopharma, Inc.
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 +1 more
Enrollment 400 participants
Start Date 2026-01-12
Primary Completion 2029-12 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-04