New cell therapy aims to reduce inflammation in ALS patients
Official title: Intermediate-Size Expanded Access Trial of Autologous Hybrid TREG/Th2 Cell Therapy (RAPA-501) of Amyotrophic Lateral Sclerosis
Funded at Massachusetts General Hospital · NIH-10934366 · Data updated 2026-11-12
This study is testing a new treatment called RAPA-501, made from your own cells, to help reduce inflammation and improve breathing for people with ALS who can't join other studies because of their lung function.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Massachusetts General Hospital NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project start | September 25, 2023 |
| Project end | August 31, 2026 |
| Funding year | 2024 |
| Award (this year) | $11,665,635 |
| NIH project number | 5U01NS136020-02 |
| Project ID | NIH-10934366 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are patients with ALS who have a slow vital capacity (SVC) value of less than 50% of predicted normal and are considered high risk for respiratory failure.
✕Less likely to help
Patients with ALS who have SVC values above 50% or those who are currently participating in other ALS clinical trials may not benefit from this research.
What this research studies
This research investigates a novel autologous T cell therapy called RAPA-501, designed to reduce inflammation in patients with Amyotrophic Lateral Sclerosis (ALS). The therapy is manufactured from the patient's own cells and aims to stabilize pulmonary function and improve overall health outcomes. The trial specifically targets patients who are not eligible for other ALS studies due to their respiratory function being below a certain threshold. By focusing on a high-risk population, the research seeks to provide a new treatment option for those with limited alternatives.
Why it matters
Potential benefit: If successful, this research could significantly improve the quality of life and survival rates for ALS patients by addressing the underlying inflammation associated with the disease.
How similar studies have gone: Previous research has shown promising results with similar T cell therapies in other inflammatory conditions, suggesting potential for success in this novel application for ALS.
Where this research is happening
-
Massachusetts General Hospital
Boston, United States Active
Researchers
- Principal investigator: Berry, James Dale — Massachusetts General Hospital
- Study coordinator: Berry, James Dale
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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.