NCT04823624

MBG453 in Lower Risk MDS

TIM3 Inhibition With MBG453 for Patients With Lower Risk MDS: an Adaptive Two-Stage Phase II Clinical Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is assessing the efficacy of MBG-453, a humanized monoclonal antibody, in treating myelodysplastic syndromes (MDS). The name of the study drug involved in this study is MBG453.

Detailed description

This is an adaptive two-stage phase II clinical trial to assess the activity of the anti-TIM-3, (T cell immunoglobulin domain and mucin domain) antibody, MBG453, in patients with lower-risk myelodysplastic syndromes (MDS), not eligible for or progressing on frontline therapy. The U.S. Food and Drug Administration (FDA) has not approved MBG453 for myelodysplastic syndromes (MDS), but it has been approved for other uses. The study drug (MBG453) may interact with TIM-3 (an antibody which is a protein that attaches to foreign infectious/invading cells and signals the immune system) which might aid the immune system's response by helping immune cells recognize, find, and destroy cancer cells in the body. The research study procedures include screening for eligibility and study treatment, including evaluations and follow up visits. Participants will receive study treatment for as long as they and their doctor believe they are benefiting from the study drug. Participants will then be followed for 12 months after their last dose of the study drug or until they withdraw their consent to be contacted. It is expected that about 20 people will take part in this research study

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	MBG453	intravenous infusion

Timeline

• Start date: 2022-01-27
• Primary completion: 2024-11-12
• Completion: 2025-11-01
• First posted: 2021-04-01
• Last updated: 2026-02-27
• Results posted: 2026-02-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study