Lyell Immunopharma reports safety data for lymphoma CAR T-cell therapy

Lyell Immunopharma Inc. (NASDAQ: LYEL) presented updated safety and translational data for its CAR T-cell therapy rondecabtagene autoleucel in patients with large B-cell lymphoma at the European Hematology Association 2026 Congress.

The company reported treating more than 100 patients with relapsed or refractory large B-cell lymphoma in second-line and third-line or later settings, achieving a 97% manufacturing success rate. The treatment showed no Grade 3 or higher cytokine release syndrome events and low rates of Grade 3 or higher immune effector cell-associated neurotoxicity syndrome.

The study included 108 patients with a median age of 64 years. Among patients receiving dexamethasone prophylaxis, 56% experienced Grade 1 cytokine release syndrome and 13% experienced Grade 2 events. For those without prophylaxis, 30% had Grade 1 and 39% had Grade 2 events. Grade 3 or higher neurotoxicity occurred in 8% of patients with prophylaxis versus 16% without prophylaxis.

Translational research showed that cytotoxic T cells with memory potential were more abundant in patients with durable responses lasting more than 12 months compared to those with progressive disease. The therapy demonstrated dual-targeting of CD19 and CD20 antigens.

"The updated safety profile, with no Grade 3 or higher CRS and low rates of Grade 3 or higher ICANS, supports outpatient administration," said Lynn Seely, the company's chief executive officer.

Lyell expects updated data from its PiNACLE trial in the second half of 2026, with pivotal data by mid-2027 and a biologics license application submission in the second half of 2027.

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