Repeat PET/CT Imaging of Patients With Amyloid 124I-AT-01 to Measure Changes in Organ-specific Amyloid Load

NCT05968846 | Completed Phase 2 FDA Drug

• 1 other identifier: UTMC-AT01-163117
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research study is to determine whether changes in organ-specific uptake of 124I- AT-01 can be measured by PET/CT imaging and further, whether these values correlate with changes in a subject's disease status and thereby enable monitoring of disease response over time in terms of organ-specific amyloid load.

Conditions

Systemic Amyloidosis

Keywords

systemic amyoidosis; p5+14; AT-01; PET/CT; evuzamitide

Outcome Measures

Primary Outcomes (1)

• To measure visual and quantitative changes in organ-specific uptake of 124I-AT-01

  The goal of this research study is to determine whether changes in organ-specific uptake of 124I- AT-01 can be measured by PET/CT imaging and further, whether these values correlate with changes in a subject's disease status and thereby enable monitoring of disease response over time in terms of organ-specific amyloid load. The specific aim of this study is to measure visual and quantitative changes in organ-specific uptake of 124I-AT-01 from baseline, in patients with systemic amyloidosis, using PET/CT imaging.

  From enrollment to the end of the study is 8 days

Other Outcomes (6)

• Measures of Interest

  From enrollment to the end of the study is 8 days

• Measure of Interest

  From enrollment to the end of the study is 8 days

• Measure of Interest

  From enrollment to the end of the study is 8 days

Study Arms (1)

Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging

EXPERIMENTAL

124I-AT-01 (124I-p5+14, iodine-124I evuzamitide) is an iodine-124 (124I) labeled 45 L-amino acid peptide suitable for PET/CT imaging. The peptide binds many forms of amyloid through multivalent electrostatic interactions with the amyloid fibril and ubiquitous heparan sulfate proteoglycans. 124I-AT-01 has been evaluated previously in an open-label Phase 1/2 clinical trial, AMY1001, performed at the University of Tennessee Medical Center (IND# 132282; NCT T03678259). In this repeat imaging study, patients previously enrolled in the AMY1001 study, in whom positive PET/CT imaging findings were observed will undergo repeat imaging to assess changes in radiotracer uptake in the liver, spleen, heart and kidneys.

Drug: Injection of peptide p5+14 radiolabeled with iodine-124 (124I-AT-01)

Interventions

Injection of peptide p5+14 radiolabeled with iodine-124 (124I-AT-01) DRUG

124I-AT-01 (124I-p5+14, iodine-124I evuzamitide) is a a novel iodine-124 (124I) labeled 45 L-amino acid peptide suitable for PET/CT imaging that has been shown to bind systemic amyloid deposits of diverse types in all organs, including the heart. The peptide binds amyloid through multivalent electrostatic interactions with the amyloid fibril and ubiquitous heparan sulfate proteoglycans.

Also known as: 124I-p5+14, iodine-124-evuzamitide

Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
• Must have a diagnosis of systemic amyloidosis based on the patient's medical record.
• Must have undergone PET/CT imaging with 124I-AT-01 as part of the AMY1001 study (IND #132282) with visually positive uptake of radiotracer in at least one abdominothoracic organ.
• Must have been imaged with 124I-AT-01 as part of the AMY1001 study (IND #132282) more than 12 months prior to repeat imaging.
• Females: must be non-pregnant and non-lactating and either: surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy); post-menopausal (defined as 12 months of spontaneous amenorrhea in females \> 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the laboratory involved).

You may not qualify if:

• Disabling dementia or other mental or behavioral disease.
• Patients on dialysis.
• Inability or unwillingness to comply with the study requirements.
• Patients taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation.
• Other reason that would make the subject inappropriate for entry into this study.
• Inability to lie still for 60 minutes on the PET/CT scanner.
• History of iodine (potassium iodide) allergy.
• Positive ADA finding defined as significantly higher than normal human serum mean values AND with a mean value at least five times greater than the mean value of the normal human serum control.

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis

Interventions

Iodine-124

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: August 1, 2023
• Study Start: December 7, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)