The pharmaceutical company Grifols—has started dosing patients in the final stage (Phase 3) of two clinical trials. The company is trying to get approval to use two of its antibody-based therapies for new medical conditions.

Both treatments utilize immunoglobulins, which are healthy antibodies collected from plasma donors that help patients fight off illnesses or regulate their immune systems.

1. The SIGMA Trial: Preventing Infections in Cancer Patients  (NCT07582432)

This trial is testing a medicine called GAMUNEX-C, which is given intravenously (delivered directly into a vein through an IV).

• Who it helps: Patients with SID (Secondary Immunodeficiency). This is a condition where a person’s immune system is severely weakened and cannot make enough protective antibodies on its own. It is “secondary” because it is caused by an outside factor, such as another disease or a medical treatment.
• The specific focus: The study is looking at people with three common types of blood cancer: chronic lymphocytic leukemia, multiple myeloma, and non-Hodgkin lymphoma. Together, these cancers affect more than 1 million people in the U.S. (United States).
• The goal: To see if adding this antibody treatment to a patient’s standard cancer therapy can successfully protect them from getting infections.

2. The XPERT Trial: A More Convenient Nerve Treatment (NCT07540221)

This trial is testing a medicine called XEMBIFY, which is given subcutaneously (injected into the fatty tissue just under the skin), to see if it can be a simpler alternative to IV treatments.

• Who it helps: Patients with CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy). This is a rare, long-term neurological disorder where the body’s immune system mistakenly attacks its own nerves. It affects about 60,000 people in the U.S. and causes progressive weakness in the arms and legs, as well as numbness or loss of feeling.

The goal: To find out if the way XEMBIFY moves through and acts inside the body is just as effective as the current standard IV option, GAMUNEX-C. Right now, GAMUNEX-C is a primary treatment that helps calm the overactive immune system, improves muscle movement, and keeps symptoms from coming back.