NCT05470283

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to find the recommended dose of OBX-115 in combination with acetazolamide that can be given to patients with metastatic melanoma previously treated with immune checkpoint inhibitors. The safety and tolerability of the study drug combination will also be studied.

Detailed 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)

Conditions

• Tumor
• Metastatic Melanoma
• Melanoma

Interventions

Type	Name	Description
DRUG	OBX-115	Given by IV
DRUG	Acetazolamide	Given by PO
DRUG	Cyclophosphamide	Given by IV
DRUG	Furosemide	Given by IV
DRUG	Mesna	Given by IV
DRUG	Fludarabine Phosphate	Given by IV

Timeline

• Start date: 2022-09-07
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2022-07-22
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study