The OM336-AIC-1001 trial for autoimmune cytopenia is enrolling!
Ouro Medicines is studying a new, investigational drug for the treatment of people with autoimmune cytopenias, which includes diseases such as Autoimmune Hemolytic Anemia (AIHA) and Immune Thrombocytopenia (ITP).
What are autoimmune cytopenias?
Autoimmune cytopenias are diseases where the body's immune system targets healthy blood cells, causing them to be destroyed faster than normal. This can lead to low levels of one or more types of blood cells, such as red blood cells and platelets. These low blood cell counts may cause signs and symptoms like fatigue (feeling tired), easy bruising, and excessive bleeding.
What is the OM336-AIC-1001 clinical trial?
In the Ouro clinical trial, doctors are testing OM336, a new BCMA x CD3 T cell engager drug, in people who still have active AIHA or ITP after taking standard medications. Doctors want to find out how safe and effective OM336 is in people with these autoimmune cytopenias.
How does OM336 work?
T cell engager drugs work by activating the patient’s own immune system to kill certain B cells, and OM336 is being tested in people with autoimmune diseases that are caused by these types of B cells. OM336 is given by an injection just under the skin (a subcutaneous injection).
Who can take part in the OM336-AIC-1001 clinical trial?
You may be able to participate in the OM336-AIC-1001 trial if:
- You are 18 years or older
- You have been diagnosed with at least one autoimmune cytopenia, such as AIHA or ITP
- You have tried other medicines to treat your autoimmune cytopenia, but still have active disease
This list does not include all the trial participation criteria. For additional information, please see https://clinicaltrials.gov/study/NCT07083960.
If you want to find out if you can take part in the trial, your healthcare provider can refer you to a trial site. The trial doctor will discuss your options with you and if you agree to continue, you will have some tests to see if you qualify for the trial, which can include physical examinations, chest X-rays, and blood and urine tests.
This trial is taking place at clinical sites in the United States, Australia, and in the UK. You may need to travel if you do not live near a trial site.
What will happen in the OM336-AIC-1001 Trial?
If you qualify for the trial, you will need to come to in-person visits at the clinical trial site. In the first 3 weeks, you will have injections of OM336 and after that you will continue to have appointments with the study doctor at the clinical trial site for one year, to check on your health and on the activity of your autoimmune cytopenia. Everyone in this study will receive active OM336, there is no placebo (inactive drug) given.
For more information contact clinical@ouromeds.com