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A Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the Body

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: REGN7999 (drug), Placebo (drug)
How long the study runs: Study runs about 27 months (dates as stated)
About the drug or intervention: REGN7999 — drug: Administered subcutaneous (SC) · Placebo — drug: Administered SC
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years to 65 Years
Who: All
Number of participants: 19
Started: 2024-09-30
Last checked: 2026-06

Plain English Summary

What is this study?

• Testing a new treatment for non-transfusion dependent beta-thalassemia (ntdt)
• Phase2 - 19 participants
• This study is researching an experimental drug called REGN7999 (called "study drug")

Who can take part?

• Ages 18 Years to 65 Years
• Diagnosed with non-transfusion dependent beta-thalassemia (ntdt)

Where?

• London - University College London Hospitals NHS Trust
• London - Imperial College Healthcare NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This study is researching an experimental drug called REGN7999 (called "study drug"). The study is focused on patients with non-transfusion dependent beta-thalassemia. The aim of the study is to see how safe and effective the study drug is. The study is looking at several other research questions, including: * Whether the study drug lowers extra iron levels in the body * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Non-Transfusion Dependent Beta-Thalassemia (NTDT)

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years - 65 Years
Who can join: All genders

What the study is looking for

✓Clinical diagnosis of NTDT as described in the protocol
✓IOL, defined as LIC ≥ 5 mg Fe/g DW as measured by R2\* MRI at screening
✓Serum ferritin ≥ 300 ng/mL as described in the protocol

Who cannot take part

✗red blood cell level ≤ 8 g/dL at screening
✗Any RBC transfusion within 12 weeks of visit 3
✗For Part A only: Any Iron Chelation Therapy (ICT) use in approximately 12 weeks prior to screening as described in...
✗For Part B only: If on ICT, any change in ICT dose in approximately 12 weeks prior to screening as described in the...
✗Any use of luspatercept or mitapivat in 6 months prior to screening as described in the protocol

See the full criteria

Key Inclusion Criteria: 1. Clinical diagnosis of NTDT as described in the protocol 2. IOL, defined as LIC ≥ 5 mg Fe/g DW as measured by R2\* MRI at screening 3. Serum ferritin ≥ 300 ng/mL as described in the protocol Key Exclusion Criteria: 1. Hemoglobin ≤ 8 g/dL at screening 2. Any RBC transfusion within 12 weeks of visit 3 3. For Part A only: Any Iron Chelation Therapy (ICT) use in approximately 12 weeks prior to screening as described in the protocol 4. For Part B only: If on ICT, any change in ICT dose in approximately 12 weeks prior to screening as described in the protocol 5. Any use of luspatercept or mitapivat in 6 months prior to screening as described in the protocol 6. Absolute contraindication to MRI 7. Diagnosis of cirrhosis of the liver 8. Diagnosis of Chronic kidney disease (CKD) stage 4 or higher Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Where Is This Study? (2 UK sites)

University College London Hospitals NHS Trust

London NW1 2PG, United Kingdom

Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net 020 3447 9825

Imperial College Healthcare NHS Trust

London W12 0HS, United Kingdom

Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net ---

Data sourced from ClinicalTrials.gov · Last verified: 2026-06