What is Chimeric Antigen Receptor (CAR) T-cell therapy?
KYSA-6 uses miv-cel (mivocabtagene autoleucel, formerly KYV-101), a CAR T-cell therapy. Miv-cel is a novel approach that is administered one time and is made from a person's own immune cells, specifically the T cells, to fight disease. Miv-cel works by eliminating B cells, including unhealthy B cells that produce autoantibodies, which may contribute to disease activity in MG.
Miv-cel is a fully human, autologous, CD19 CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, which is under investigation for B-cell-driven autoimmune diseases. With a single administration, miv-cel has potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases. This is the first study using miv-cel in generalized MG, but miv-cel has been used to treat people with generalized MG under a form of compassionate use treatment. People with other autoimmune conditions have also been treated with miv-cel.
CAR T-cell therapies can be associated with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which may be potentially serious or life-threatening but generally resolve within the first month after treatment.
- Symptoms of CRS include fever, nausea, feeling tired (fatigue), and body aches and can progress in severity and may include low blood pressure, shock, and potentially organ failure.
- Symptoms of ICANS include fatigue, uncontrolled movements (tremors), impairment in thinking, loss of speech, muscle weakness, or more severe symptoms such as seizures and swelling in the brain.
People receiving this treatment are always in the care of a doctor, who monitors them closely for these side effects and can treat their symptoms to help prevent their worsening.
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