SOUTH SAN FRANCISCO, Calif., June 12, 2026
Lyell Immunopharma, Inc. announced updated safety and translational data for rondecabtagene autoleucel (ronde-cel) from its ongoing Phase 1/2 clinical trial in patients with relapsed or refractory large B-cell lymphoma (LBCL) at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden. The data demonstrated a favorable safety profile across more than 100 treated patients and provided new insights into the biological mechanisms supporting durable clinical responses. The company reported a 97% manufacturing success rate, reinforcing the consistency and scalability of its next-generation CAR T-cell platform.
Ronde-Cel Demonstrates Favorable Safety Profile in LBCL
Updated findings from 108 treated patients showed that ronde-cel maintained a manageable safety profile across both second-line and third-line-plus treatment settings. Importantly, no Grade 3 or higher Cytokine Release Syndrome (CRS) events were reported, while rates of severe Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) remained low. Among patients receiving dexamethasone prophylaxis, Grade 3 or higher ICANS occurred in only 8% of patients compared with 16% in those who did not receive prophylaxis. These results further support the potential for outpatient administration, a significant advantage in CAR T-cell therapy delivery.
Translational Data Reveal Mechanisms Behind Durable Responses
Lyell also presented translational research highlighting the biological factors associated with long-lasting responses to ronde-cel. Single-cell RNA sequencing analyses demonstrated that the therapy’s CD62L-enriched CAR T-cell population contained a higher proportion of cytotoxic T cells with memory potential compared with currently approved CD19-targeted CAR T-cell therapies. These specialized cells showed enhanced survival, expansion, and anti-tumor activity, providing a potential explanation for the durable responses observed in patients. Additionally, the therapy’s dual-targeting CD19/CD20 design may help overcome challenges related to low antigen expression, a common mechanism of treatment resistance.
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Pivotal Development Program Advances Toward Regulatory Milestones
Lyell Immunopharma continues to advance ronde-cel through two pivotal clinical programs. The ongoing PiNACLE trial in third-line and later LBCL is expected to provide an updated data readout during the second half of 2026, with pivotal results anticipated by mid-2027. A subsequent Biologics License Application (BLA) submission is planned for the second half of 2027. The company is also conducting the Phase 3 PiNACLE-H2H trial, which compares ronde-cel against currently available CAR T-cell therapies in second-line LBCL. Collectively, the updated clinical and translational findings strengthen ronde-cel’s position as a potential next-generation CAR T-cell therapy designed to deliver durable responses with a favorable safety profile for patients with difficult-to-treat lymphoma.
Source: Lyell Immunopharma press release
