New cell therapy aims to reduce inflammation in ALS patients

Intermediate-Size Expanded Access Trial of Autologous Hybrid TREG/Th2 Cell Therapy (RAPA-501) of Amyotrophic Lateral Sclerosis

NIH-funded research Massachusetts General Hospital · NIH-10934366

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 typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionMassachusetts General Hospital NIH-funded
Lab location1 site (Boston, United States)
Project IDNIH-10934366 on NIH RePORTER

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.

Who could benefit from this research

Good fit: 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.

Not a fit: 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.

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 performed: 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

Boston, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Amyotrophic Lateral Sclerosis Motor Neuron Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.