Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma

Description

Primary Objective:

• Assess the safety and tolerability of OBX-115 + acetazolamide by CTCAE version 5 criteria to provide a recommended Phase II dose

Secondary Objectives:

* Assess preliminary efficacy of OBX-115 + acetazolamide cell therapy in patients with immune checkpoint inhibitor (ICI)-relapsed and/or refractory metastatic melanoma by evaluating overall response rate (ORR; complete response [CR] + partial response [PR]) by RECIST 1.1 criteria
* Evaluate feasibility of the manufacturing process
* Evaluate duration of response (DOR)
* Evaluate progression free survival (PFS)
* Characterize in vivo cellular kinetics of OBX-115 cells in tumor and/or in peripheral blood by polymerase chain (PCR) and/or fluorescence-activated cell sorting (FACS) analyses
* Characterize the pharmacokinetic profile of acetazolamide when administered in combination with OBX-115
* Characterize the incidence and prevalence of OBX-115 therapy immunogenicity

Exploratory Objectives:

* Assess relationship of soluble immune factors and pharmacodynamic markers, with cellular kinetics, safety, and efficacy
* Describe the composition of OBX-115 subsets (immunophenotyping in peripheral blood mononuclear cells [PBMCs] and in tumor), summarized by clinical response
* Explore the correlation of OBX-115 kinetics in tumor and peripheral blood with clinical endpoints
* Explore the correlation of immune checkpoints with OBX-115 cellular kinetics and efficacy
* Evaluate overall survival (OS)