RAPA-501 Therapy for ALS

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Rapa Therapeutics LLC
Study ID
NCT04220190
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Jan 2, 2025
Status verified
Jun 2025
Primary completion
Jul 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

In the expansion cohort enrolling standard-risk pwALS, determine the feasibility and safety of the highest established safe dose of RAPA-501 (80 x 10^6 cells per infusion). [ Time Frame: Through 30 Weeks On-Study ]

Central Contacts

  • Daniel Fowler, M.D. Chief Medical Officer, RAPA Therapeutics, LLC
    (301) 518-3104
    [email protected]
  • Jennifer Sunga Regulatory Affairs Associate, RAPA Therapeutics, LLC
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Megan Okoro
[email protected]
617-643-6252
Shannon Chan
[email protected]
617-643-4968
James Berry, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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