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A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT05235269•Attralus, Inc.

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Understands the study procedures and is capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
•2. Male or female ≥18 years of age.
•3. For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 90 days after the last dose of 124I-AT-01.
•1. A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state, and has not undergone surgical sterilization.
•2. Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
•3. Contraception methods that do not result in a failure rate of \<1% per year such as cap, diaphragm, or sponge with spermicide, or male or female condom with or without spermicide, are not acceptable.
•4. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
•4. For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, as defined below:
•a) With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \<1% per year during the treatment period and for at least 120 days (a spermatogenesis cycle) after the last dose of study intervention. Men must refrain from donating sperm during this same time period.
•5. Able to undergo two PET/CT scans as part of the study, including ability to lie supine for up to 1 hour.
+3 more criteria

Exclusion Criteria

•1. Is pregnant or breast-feeding.
•2. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
•3. Has received in the last 6 months or are currently receiving treatment with anti-amyloid monoclonal antibody therapy or are expected to begin treatment prior to completing this study.
•4. Has received heparin or heparin analogs within 7 days of Day 1.
•5. Has a significant co-morbidity (e.g., Easter Cooperative Oncology Group (ECOG) score of 3 or greater), New York Heart Association (NYHA) Class IV heart failure, uncontrolled infection, or other ongoing serious illness.
•6. Has active thyroid disease.
•7. Has a known allergy to potassium iodine treatment.
•8. Is receiving hemodialysis or peritoneal dialysis.
•9. Has severe claustrophobia that would prevent completion of the PET/CT imaging protocol.
•10. Has received an investigational agent within five half-lives of the agent or 30 days, whichever is longer, prior to Screening.
+1 more criteria

Locations (3)

PET/CT Imaging of Berkeley

Berkeley, California, United States

Northern California PET Imaging Center

Sacramento, California, United States

PET/CT Imaging of San Jose

San Jose, California, United States

Key Dates

Start Date

November 30, 2021

Primary Completion Date

February 6, 2023

Completion Date

February 24, 2023

Last Updated

September 4, 2025

Enrollment

ACTUAL participants

Conditions

Amyloidosis

Interventions

124I-AT-01

DRUG

Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

NCT06192979

Amyloidosis; SystemicAL Amyloidosis

View study

RECRUITINGPHASE1

Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis

NCT07250269

Relapsed/Refractory AL Amyloidosis

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

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