Table of contents
What is cizutamig?
Cizutamig is a protein-based, bispecific T-cell engaging antibody. It is an investigational substance, meaning it has no marketing authorisation in the product records and is not yet approved as a medicine.[1] The substance is supplied by Candid Therapeutics Inc. and is also known simply as cizutamig.
How does cizutamig work?
Cizutamig is designed to bind to two targets: BCMA on certain immune cells and CD3 on T cells. By linking these cells, it aims to direct T cells to attack BCMA-expressing cells. The trial data do not provide further details on the mechanism, but the primary focus is on safety in patients with immune-mediated inflammatory diseases.[1]
Which conditions is cizutamig studied for?
The SPLENDID trial is studying cizutamig in four severe, treatment-refractory immune-mediated inflammatory diseases:
- Primary Sjögren's disease (pSjD) – a condition where the immune system attacks glands that produce tears and saliva.
- Idiopathic inflammatory myopathy (IIM) – a group of diseases causing muscle inflammation and weakness.
- Systemic sclerosis (SSc) – a disease causing hardening and tightening of the skin and connective tissues.
- Rheumatoid arthritis (RA) – seropositive RA with anti-citrullinated protein antibody and/or rheumatoid factor, a condition causing joint inflammation and damage.
How is cizutamig given?
Cizutamig is given as a solution for infusion, administered by intravenous infusion.[1]
What do the clinical trials show?
One clinical trial, the SPLENDID trial, is investigating cizutamig. It is a Phase 1, open-label study that has been authorised. The trial plans to enrol 12 participants with severe, treatment-refractory immune-mediated inflammatory diseases.[1]
The primary outcome measures safety, specifically the incidence and severity of cytokine release syndrome (CRS), immune cell associated neurotoxicity syndrome (ICANS), and treatment-emergent adverse events until 28 days after the last administration of cizutamig.[1]
What side effects are known?
The trial is designed to assess safety, including cytokine release syndrome and immune cell associated neurotoxicity syndrome, but no detailed side effect data are available from the registry record.[1]