Clinical Trials Logo
  1. Home
  2. Amyloidosis
  3. NCT05235269

A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis — AT01-001  

Amyloidosis Clinical Trial

Official title:
A Multicenter, Open-label, Single-arm, Phase 2 Study to Evaluate Safety and Organ Uptake Quantitation Repeatability of 124I AT-01 Using Positron Emission Tomography/X-ray Computed Tomography (PET/CT) in Subjects With Systemic Amyloidosis

Clinical Trial Summary

This study is designed to assess the repeatability of organ-specific quantitation of radiotracer uptake following Positron Emission Tomography/Computed Tomography (PET/CT) imaging of AT- 01 in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis.

Clinical Trial Description

This is a multicenter, open label, single arm study in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis with visceral amyloid deposits. This study consists of a screening period of up to 30 days; two one-day treatment periods (Day 1 and Week 6); a safety follow-up 24-48 hours after the second administration of 124I AT-01, and a safety follow-up visit 28 days after the second administration of 124I-AT-01. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05235269
Study type Interventional
Source Attralus, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 30, 2021
Completion date December 30, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04893889 - Substudy (NCT04456582): Noninvasive Assessment of Myocardial Stiffness by 2D-SWE Ultrasound Technique (Two-dimensional Shear Wave Elastography) in Patients With Amyloidosis and Fabry Disease. N/A
Withdrawn NCT04943302 - Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis Phase 2
Active, not recruiting NCT02909036 - Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant. Phase 1
Completed NCT02816476 - Daratumumab Therapy for Patients With Refractory or Relapsed AL Amyloidosis Phase 2
Completed NCT01083316 - Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis Phase 2
Completed NCT01527032 - Risk-adapted Therapy for Primary Systemic (AL) Amyloidosis Phase 2
Completed NCT02545907 - A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis Phase 1/Phase 2
Recruiting NCT05263817 - A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis Early Phase 1
Active, not recruiting NCT03201965 - A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis Phase 3
Withdrawn NCT02589860 - Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
Recruiting NCT05635266 - A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Completed NCT02574676 - Quality of Life (QOL) Registry for Patients With AL Amyloidosis
Active, not recruiting NCT02260466 - Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement. N/A
Withdrawn NCT02462213 - Prospective Identification of Cardiac Amyloidosis by Cardiac Magnetic Resonance Imaging N/A
Recruiting NCT05577819 - Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF N/A
Completed NCT01406314 - SAP Depleter Dose Assessment Study in Patients Phase 1
Not yet recruiting NCT04985734 - Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM) in Patients With Idiopathic Peripheral Neuropathy N/A
Active, not recruiting NCT03584022 - Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial N/A
Active, not recruiting NCT05199337 - Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis Phase 1/Phase 2
Completed NCT02716103 - Assessment of Minimal Residual Disease (MRD) After Antineoplastic Treatment in Patients With AL Amyloidosis