Regulatable membrane-bound IL-15 engineered TIL cell therapy for immune checkpoint inhibitor-resistant advanced melanoma: pooled analysis of phase 1 and 1/2 trials.

Amsokigene autoleucel (amsoki-cel, OBX-115) with acetazolamide regulation shows no dose-limiting toxicities across 37 ICI-resistant advanced melanoma patients, with RP2D enabling responses.

• Why it matters: ICI-resistant advanced melanoma needs new TIL strategies that avoid IL-2 dependence while maintaining safety and early anti-tumor activity.
• What they did: In two single-arm trials (FIH phase 1 and Agni-01 phase 1/2), patients received lymphodepletion plus varying amsoki-cel doses and ACZ, with protocol changes after a first-patient brain-metastasis edema event.
• The result: Across studies, grade 3+ TEAEs most often included neutropenia (64.9% (24/37)) and leukopenia/lymphopenia (56.8% (21/37) each), and the phase 2 preliminary ORR was 66.7% (6/9).

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