AdventHealth Neuroscience Institute Administers First Dose of Investigative NK Cell Therapy to Person with Alzheimer’s Disease

Under a single compassionate use Investigational New Drug (IND) authorization cleared by the U.S. Food and Drug Administration (FDA), the AdventHealth Neuroscience Institute worked with NKGen Biotech to administer the first dose of troculeucel (SNK01), an expanded autologous natural killer (NK) cell therapy, on July 10, 2025, to a patient with Alzheimer’s disease who exhibited continued cognitive decline despite ongoing treatment with lecanemab, an amyloid targeting therapy. AdventHealth Neuroscience Institute Director of Neuroscience Clinical Research Anita Fletcher, MD, a board-certified neurologist with specialized training in neuroimmunology, is conducting this exploratory work with NKGen Chairman and Chief Executive Officer Paul Y. Song, MD.

AdventHealth Orlando is also the first site on the East Coast and among the first in the nation to offer an ongoing Phase IIa clinical trial to evaluate the safety, tolerability and efficacy of troculeucel (SNK01) in participants with moderate Alzheimer’s disease. Dr. Fletcher serves as National Principal Investigator for the study and expects to enroll the first patient at the Central Florida site soon.

Exploring New Treatment Options for Alzheimer’s Disease
Nearly 7 million Americans age 65 and older are living with Alzheimer’s, and without development of effective treatments or a cure for the disease, that number is expected to grow to 12.7 million by 2050. The FDA has approved two monoclonal antibody intravenous (IV) infusion therapies for the treatment of mild Alzheimer’s disease — lecanemab (Leqembi®) and donanemab (Kisunla™). Both are targeted anti-amyloid therapies and have been shown to slow the rate of cognitive decline in some patients but do not halt disease progression or improve cognitive function.

Troculeucel is a novel cell-based, patient-specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate. Administered as an outpatient infusion, it was developed by NKGen Biotech for the treatment of neurodegenerative disorders and oncology indications.

“The inflammatory changes that lead to neurodegeneration, including Alzheimer’s disease, are critical and unexplored and could provide a new mechanism for achieving meaningful clinical benefit,” shares Dr. Fletcher. “We need to look beyond the amyloid targeting pathway and identify additional interventions in patients for whom other treatments have not been appropriate or effective. If we can show that troculeucel can improve cognitive function in patients who continue to progress on amyloid targeting therapy, that would be a huge step forward, providing new hope to the millions of people suffering from Alzheimer’s disease.”

To learn more, visit BrainHealthFlorida.comhttp://brainhealthflorida.com/.