Abstract CT244: Trial in progress: Phase 1/2 study of OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced solid tumors
Abstract
Non-engineered TIL cell therapy was recently approved for patients with immune checkpoint inhibitor (ICI)-resistant melanoma (Chesney JITC 2022) and shows promising efficacy in non-small cell lung cancer ([NSCLC]; Creelan Nat Med 2021, Schoenfeld Cancer Discov 2024), but has a treatment-related mortality rate of 7.5% in melanoma and requires co-administration of systemic high-dose IL2, with well-described high-grade toxicity. OBX-115 TIL are expanded from patient tumor tissue and engineered with a transgene to express membrane-bound human IL15 (mbIL15), regulated by acetazolamide (ACZ), eliminating the need for IL2. A first-in-human single-institution study evaluating the safety of OBX-115 in metastatic melanoma has completed enrollment (NCT05470283; Amaria ASCO 2024). The current study (NCT06060613) is enrolling patients with melanoma and NSCLC at multiple US sites using centralized manufacturing.
This phase 1/2, single-arm, open-label, nonrandomized, multicenter study will assess the safety, tolerability, and efficacy of the OBX-115 engineered autologous TIL cell therapy regimen in patients with unresectable Stage IIIC-IV metastatic melanoma (excluding uveal) with radiographic progression after systemic therapy containing PD-1-targeted ICI (≤2 prior lines; neoadjuvant/adjuvant considered prior line if progressed during treatment or within ≤12 weeks of last dose) OR metastatic NSCLC previously treated with an approved systemic therapy for metastatic disease (including an…
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