Mobista (CDX-301)

P2, N=100, Recruiting, Weill Medical College of Cornell University | Trial primary completion date: Dec 2025 --> Dec 2026

P1, N=14, Active, not recruiting, University of Southern California | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2027

P1, N=30, Recruiting, University of Texas Southwestern Medical Center | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2025 --> Apr 2026

P1, N=30, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Jan 2027 --> Sep 2030 | Trial primary completion date: Jan 2025 --> Dec 2026

Here, we report the results of a Phase II clinical trial where twenty-nine patients with advanced, previously treated NSCLC were treated with stereotactic body radiotherapy (SBRT) targeting a single site of disease along with CDX-301, a recombinant human Fms-like tyrosine kinase 3 ligand (FLT3L)...These coordinated immune responses were sustained for over 4 weeks in responders, highlighting a potential therapeutic axis engaged in a systemic immune response against multiple lesions in NSCLC. Overall, these findings underscore the potential of combining in situ vaccination, using SBRT, with strategies to enhance the activation of innate immune cells, such as DCs through FLT3L, to potentiate robust anti-tumor T cell responses.

Cohort B, which combined radiation therapy with CDX-301, poly-ICLC, and nivolumab, demonstrated encouraging clinical activity. Pre-existing rather than treatment-induced immune activation was associated with clinical benefit across cohorts, highlighting the importance of baseline immune fitness.

P2, N=33, Completed, Albert Einstein College of Medicine | Active, not recruiting --> Completed

P1, N=18, Recruiting, University of Southern California | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2025 --> Jan 2026

P1; N=45 --> 30

P2, N=33, Active, not recruiting, Albert Einstein College of Medicine | Completed --> Active, not recruiting | Trial completion date: Oct 2022 --> Oct 2024

P1, N=30, Recruiting, Dana-Farber Cancer Institute | N=20 --> 30

P2, N=16, Terminated, Washington University School of Medicine | N=24 --> 16 | Trial completion date: Mar 2024 --> Nov 2023 | Recruiting --> Terminated | Trial primary completion date: Mar 2024 --> Nov 2023; Celldex decision