troculeucel (SNK01)

P2, N=30, Recruiting, NKGen Biotech, Inc.

P1/2, N=36, Recruiting, NKGen Biotech, Inc. | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Dec 2024 --> Dec 2025

P1/2, N=11, Terminated, NKGen Biotech, Inc. | N=121 --> 11 | Trial completion date: Nov 2025 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Sep 2023; Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.

P1, N=10, Terminated, NKGen Biotech, Inc. | N=30 --> 10 | Recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Aug 2023; The study was terminated after completing the dose escalation portion of the study. The expansion cohort was not initiated to conduct a global trial based on the approved US IND using a new manufacturing process.

P1/2, N=36, Recruiting, NKGen Biotech, Inc.

P1, N=27, Completed, NKGen Biotech, Inc. | Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Feb 2023

SNK01 was safe and well tolerated. SNK01 appears to have clinical activity in AD while reducing neuroinflammation and protein levels. These results justify a larger trial with a higher dosing and longer treatment duration which will be initated in late 2023.

P1, N=27, Active, not recruiting, NKGen Biotech, Inc. | Trial completion date: May 2023 --> Sep 2023

Autologous NK cells can enhance the long-term OS and PFS for NSCLC. A larger study is needed to confirm this result. Clinical Research Information Service number: KCT0003463.

Efficacy will also be assessed by assessing progression-free and overall survival. Secondary endpoints for both phases include treatment-emergent adverse events, serious adverse events, pharmacokinetics and immunogenicity.

Furthermore, the median PFS was higher in the SNK01 combination group (6.2 vs. 1.6 months; p=0.001). Based on the findings of this study, the NK cell combination therapy may consider as a safe treatment method for stage IV NSCLC patients who had a history of failed platinum-based therapy without an increase in adverse events (AEs).

After completing the 3 Cohorts of single dose escalation of SNK01, the protocol was amended to include Cohort 4 (n=18) wherein SNK01 is given in combination with an immune checkpoint inhibitor (avelumab or pembrolizumab). The trial is currently in progress and 16/18 patients have been enrolled to date.