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RAPA-501 Therapy for ALS

NCT04220190 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-06-18

No results posted yet for this study

Summary

RAPA-501-ALS is a phase 2/3 expansion cohort study of RAPA-501 autologous hybrid TREG/Th2 cells in patients living with amyotrophic lateral sclerosis (pwALS).

Conditions

Interventions

BIOLOGICAL

RAPA-501 Autologous T stem cells

Experimental: Phase 2/3 Expansion Cohort, Single-agent RAPA-501 T stem cells 80 x 10EE6 cells per infusion (no host conditioning)

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Rapa Therapeutics LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2026-07-01
Completion
2027-06-01
FDA Drug
Yes

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 NCT04220190 on ClinicalTrials.gov