Lyell Immunopharma reported a 97% manufacturing success rate for its ronde-cel CAR-T therapy as safety data from more than 100 lymphoma patients supported the potential for treatment to be administered in an outpatient setting.
Ronde-cel is a next-generation CAR-T candidate designed to target both CD19 and CD20 in patients with relapsed or refractory large B-cell lymphoma. Unlike therapies targeting only CD19, ronde-cel uses a dual-targeting “OR” logic gate intended to maintain full potency when either CD19 or CD20 is expressed.
Lyell presented safety results from more than 100 patients, including 65 patients in the third-line or later setting and 43 in the second-line setting. No Grade 3 or higher cytokine release syndrome events were reported, while rates of Grade 3 or higher immune effector cell-associated neurotoxicity syndrome were low. The manufacturing success rate was 97%.
The safety profile could support outpatient administration, representing a meaningful potential shift for CAR-T treatment by reducing the need for prolonged inpatient care.
Lyell’s manufacturing process enriches for CD62L-positive cells to generate more naive and central memory CAR-T cells with enhanced stem-like features and antitumor activity. Translational analyses also indicated that combining CD62L-positive enrichment with dual CD19/CD20 targeting may support durable responses and overcome low antigen expression.
Ronde-cel is now being studied in two pivotal trials. The PiNACLE single-arm study is evaluating the therapy in third-line or later LBCL, with additional data expected during the second half of 2026, pivotal data expected in mid-2027, and a potential BLA submission expected in the second half of 2027.
Lyell is also enrolling patients in PiNACLE-H2H, a Phase 3 randomized study comparing ronde-cel directly with investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel in second-line LBCL. The FDA has granted ronde-cel RMAT and Fast Track designations in the third-line setting and RMAT designation in second-line LBCL.
Lyell ended June with approximately $228 million of cash, cash equivalents and marketable securities, which the company expects will provide operating runway into the third quarter of 2027.
