PDAC immunotherapy using attenuated bacteria plus low-dose gemcitabine
Official title: Clinical testing of Listeria-TT and Gemcitabine in a Phase I clinical trial with PDAC patients
Funded at Loki Therapeutics, INC · NIH-11247611 · Data updated 2026-11-12
A first-in-human study tests a new cancer immunotherapy that uses weakened bacteria to deliver immune-stimulating components to pancreatic cancer in combination with a low dose of gemcitabine.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Loki Therapeutics, INC NIH-funded |
| Lab location | 1 site (Sa, UNITED STATES) |
| Project start | June 1, 2024 |
| Project end | August 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $726,592 |
| NIH project number | 4R42CA287679-02 |
| Project ID | NIH-11247611 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with unresectable pancreatic ductal adenocarcinoma who meet study criteria and can participate in a phase II, open-label dose-escalation trial.
✕Less likely to help
Patients without PDAC or those unable to tolerate immunotherapy or gemcitabine may not benefit from this approach.
What this research studies
This project enrolls patients with unresectable pancreatic ductal adenocarcinoma to receive an investigational therapy that uses attenuated Listeria monocytogenes to deliver tetanus toxoid antigens into the tumor, aiming to re-activate memory T cells and boost anti-tumor immunity, together with low-dose gemcitabine. It is designed as a Phase II, open-label, dose-escalation study at Albert Einstein College of Medicine/Montefiore to assess safety, determine dose-limiting toxicities, and explore immune and tumor responses. Preclinical data showed tumor reduction and better survival when LM-TT was paired with gemcitabine, supporting translation to patients. The study prioritizes safety monitoring, immune profiling, and preliminary signs of clinical activity to inform future development of this immunotherapy platform.
Why it matters
Potential benefit: If successful, patients may experience better tumor control and a safer, tolerable treatment option for advanced PDAC.
How similar studies have gone: Early preclinical data and related immunotherapy strategies support potential benefit, but this exact regimen is novel in humans.
Where this research is happening
-
Loki Therapeutics, INC
Sa, United States Active
Researchers
- Principal investigator: Bradley, Chris — Loki Therapeutics, INC
- Study coordinator: Bradley, Chris
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.