Clinical Trials and Research

All About Antibodies does not endorse any specific trials. We simply post them to make the women dealing with antibodies in pregnancy aware of things that they may wish to discuss with their health care providers.

There's a new clinical trial going on for pregnant women with anti-D and anti-Kell antibodies. Many doctors do not know about this study, so if you think you are a candidate, please follow the link below to print the information and get it to your doctor ASAP. 

M281 Trial Criteria

  • Anti-D antibodies with a titer of 1:32 or higher     - OR -   anti-Kell antibodies with a titer of 1:4 or higher. 
  • Between 8 and 13 weeks gestation.
  • Previous pregnancy with problems occurring at or before 24 weeks including: 
  • Severe anemia at the time of IUT    - OR -
  • Hydrops fetalis with MoM over 1.5     - OR -  
  • Loss with placenta/pathology reports indicating severe HDFN.

Please visit  https://clinicaltrials.gov/ct2/show/NCT03842189?cond=m281&rank=3 for more information about the M281 trial and contact information for the study. Sites are opening up all the time and they will pay for travel expenses and lodging. 

What Is M281?
M281 is a monoclonal antibody that is also called  Nipocalimab. It is designed to prevent Hemolytic Disease of the Fetus and Newborn by reducing how many antibodies are in mom's system (lowering titers), and by blocking the antibodies from crossing the placenta. It is an IV infusion given every week. While the study is only for anti-D and anti-Kell, the two most aggressive antibodies, it should work for all antibodies once the trial is finished and the drug given final approval. 

Additional Links:
https://www.uth.edu/news/story.htm?id=2a52b16f-5f73-4fb7-bbd1-9bfb2aa967ff&fbclid=IwAR1SfU2g5luZvt-bNAeDo0Ah9lSWE2P9aTktAYLx8JHxegtEqwk-7TUK_D
https://www.empr.com/home/news/drugs-in-the-pipeline/nipocalimab-gets-fast-tracked-for-hemolytic-disease-of-the-fetus-and-newborn/