A Phase 3 interventional study of rondecabtagene autoleucel and axicabtagene ciloleucel in Large B-cell Lymphoma, Lymphoma, B-Cell and Relapsed Non-Hodgkin Lymphoma, sponsored by Lyell Immunopharma, Inc.. Recruiting at 36 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Lyell Immunopharma, Inc. · Phase 3, Interventional, and Treatment
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.
PiNACLE-H2H is a Phase 3 randomized controlled trial comparing the efficacy and safety of rondecabtagene autoleucel (ronde-cel, formerly known as LYL314) against the currently approved cluster of differentiation (CD)19 chimeric antigen receptor (CAR) T-cell therapies (axicabtagene ciloleucel [axi-cel] or lisocabtagene maraleucel [liso-cel]), in patients with aggressive LBCL that has relapsed or is refractory to first-line anti-CD20 antibody and anthracycline-containing chemotherapy.
Patients will be randomized (1:1) before leukapheresis to receive either:
Most patients who receive currently approved CD19-directed CAR T-cell therapies, including axi-cel and liso-cel, still experience progressive disease, often due to mechanisms such as CD19 antigen loss or T-cell exhaustion.
Ronde-cel is a novel, autologous, dual-targeting CD19/CD20 CAR T-cell product candidate enriched for CD62L-positive naïve and central memory T cells, which are associated with enhanced proliferation capacity and persistence. Ronde-cel is an "OR"-gated CAR construct that can fully activate upon recognition of either CD19 or CD20, aiming to improve durability of response despite antigen heterogeneity.
Approximately 400 participants will be enrolled. CAR T-cell therapy in both arms will be administered as a single intravenous infusion following fludarabine and cyclophosphamide lymphodepletion. Participants will be followed for 3 years for safety and efficacy, with long-term follow-up extending to 15 years.
1,411 studies on the registry are indexed under Lymphoma, B-Cell; 329 are open to participants now.
This study's planned enrollment of 400 is above the median of 36 across 1,218 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →Lyell Immunopharma, Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Biological: rondecabtagene autoleucel
axicabtagene ciloleucel, lisocabtagene maraleucel
Biological: axicabtagene ciloleucel · Biological: lisocabtagene maraleucel
An autologous, dual-targeting CD19/20 CAR T-cell candidate.
Also known as: LYL314
An autologous CD19 CAR T-cell therapy
Also known as: Yescarta, axi-cel
An autologous CD19 CAR T-cell therapy
Also known as: Breyanzi, liso-cel
Event free survival
The time interval from treatment initiation until the occurrence of a specific event of interest.
Time frame: 36 months
Overall Response Rate
Best Overall Response per Lugano Criteria
Time frame: 36 months
Complete Response Rate
Complete Response per Lugano Criteria
Time frame: 36 months
Progression Free Survial
The length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
Time frame: 36 months
Overall Survival
The length of time from either the date of diagnosis or the start of treatment for a disease, that patients diagnosed with the disease, are still alive.
Time frame: 6 years
Incidence and severity adverse events
To assess safety defined as type and frequency of AEs, serious adverse events (SAEs), and laboratory abnormalities.
Time frame: 36 months
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Lyell Immunopharma, Inc.