Study on MBG453 for Treating Lower Risk Myelodysplastic Syndromes (MDS)

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04823624

Provider View

This clinical trial is testing the effectiveness of a new drug, MBG453, in treating patients with lower-risk myelodysplastic syndromes (MDS) who have not responded to or cannot take standard treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment for lower-risk myelodysplastic syndromes (MDS) using a drug called MBG453. MBG453 is a type of antibody that may help the immune system recognize and destroy cancer cells. The study aims to see if this drug can help patients whose MDS has not improved with other treatments. Participants will receive the study drug as long as it is beneficial, and they will be monitored for 12 months after their last dose. About 20 people are expected to join this study.

Description

This clinical trial is designed to test the effectiveness of MBG453, an antibody that targets a protein called TIM-3, in patients with lower-risk myelodysplastic syndromes (MDS). These patients have not responded to or cannot take standard treatments. MBG453 is not yet approved by the FDA for MDS, but it is approved for other uses. The drug works by helping the immune system find and destroy cancer cells.

Participants will undergo screening to determine eligibility and will receive the study treatment, which includes regular evaluations and follow-up visits. They will continue treatment as long as it is beneficial, and will be followed for 12 months after their last dose or until they choose to stop participating. The study aims to enroll about 20 participants.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older with lower-risk MDS who have not responded to or cannot take standard treatments.
  • Must be dependent on red blood cell transfusions or have low blood counts that require treatment.
  • Must not have other standard treatment options available.
  • Must have adequate organ function and be in good overall health.
  • Must not have active HIV, but those with controlled HIV on treatment are eligible.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Recent chemotherapy or radiotherapy within 14 days before starting the study treatment.
  • Currently taking other investigational drugs.
  • Previous treatment with a TIM-3 inhibitor.
  • Active autoimmune disease requiring high doses of steroids.
  • History of solid organ transplant.
  • Allergic reactions to similar drugs.
  • Active untreated cancer, except for certain non-threatening types.
  • Uncontrolled health conditions.
  • Active hepatitis B or C.
  • Recent live vaccination.
  • Mental health conditions that affect study participation.
  • Women must not be pregnant or breastfeeding and must use effective contraception during and after treatment.

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