NKGen Biotech Activates Three U.S. Sites for Phase 2 Troculeucel Trial in Moderate Alzheimer's Disease

Decentralized enrollment for an autologous NK cell therapy carries manufacturing implications that site activation announcements rarely surface: NKGen Biotech has added three clinical trial sites — Rutgers Health in Newark, Alzheimer's Disease Research Center in Albany, and K2 Medical Research in Orlando — to its ongoing Phase 2 study of troculeucel in moderate Alzheimer's disease, extending the network into the Northeast for the first time.

Troculeucel is a patient-specific, ex vivo expanded autologous NK cell immunotherapeutic, meaning each enrolled patient requires an individual manufacturing batch. Geographic expansion of enrollment sites therefore scales not just patient access but the logistical and GMP burden associated with apheresis collection, chain-of-identity controls, and release testing for each unique lot. For cell therapy manufacturing teams, broader site activation typically precedes a corresponding increase in batch throughput demands.

Prior to these activations, NKGen's trial footprint was concentrated on the West Coast and in Orlando. The Northeast additions — Newark and Albany — address a documented referral gap the company acknowledged was limiting participation from eligible patients in that region. All three sites are now open for screening and enrollment under NCT06189963.

Troculeucel received its International Nonproprietary Name from the World Health Organization, a step that standardizes the drug substance designation ahead of any future regulatory submissions. For regulatory affairs leads tracking the program, INN assignment marks a formal milestone in the path toward a Biologics License Application, though NKGen has not disclosed a submission timeline.

The company noted that enrollment outcomes remain subject to patient eligibility criteria and regional referral patterns, and offered no assurance on recruitment pace — a standard but operationally relevant caveat for site coordinators managing screening capacity against uncertain patient flow.

Enrollment velocity across the expanded network will serve as an early indicator of whether the geographic redistribution translates into measurable batch demand at NKGen's manufacturing operations.

Source: NKGen Biotech via press release, May 19, 2026.