Ignite Creation Date:
2024-05-06 @ 5:55 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05470283
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2022-07-20
Brief Title:
Phase I Open-Label Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor refractory metastatic melanoma by evaluating overall response rate ORR complete response CR partial response PR by RECIST 11 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 andor in peripheral blood by polymerase chain PCR andor 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
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 andor refractory metastatic melanoma by evaluating overall response rate ORR complete response CR partial response PR by RECIST 11 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 andor in peripheral blood by polymerase chain PCR andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-06873 | OTHER | NCI-CTRP Clinical Trials Registry | None |