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RAPA-501 Therapy of ALS Expanded Access Protocol

NCT06169176 · Status: TEMPORARILY_NOT_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-02-12

No results posted yet for this study

Summary

RAPA-501-ALS is an Intermediate-Size Expanded Access Trial of RAPA-501 autologous hybrid TREG/Th2 T stem cells in patients living with amyotrophic lateral sclerosis (pwALS).

Conditions

Interventions

OTHER

RAPA-501 Autologous T stem cells

Experimental: Intermediate size expanded access cohort. Single-agent RAPA-501 T stem cells, (80 x 10EE6 cells per infusion; acceptable dose range of RAPA-501 T stem cells is 20-to-80 x 10EE6 cells per infusion.

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Rapa Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Daniel H Fowler, M.D. · Rapa Therapeutics LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06169176 on ClinicalTrials.gov