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Study identifier: NCT07070999 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Study of Safety, Tolerability and Efficacy of GB221 in Infants With Spinal Muscular Atrophy Type 1

Condition: Spinal Muscular Atrophy Type I  ·  Sponsor: Gemma Biotherapeutics

PhasePhase 1/Phase 2
Planned participants22
Who can joinAll sexes, 2 Weeks to 12 Months
Healthy volunteersNo

About this study

GB221 is a gene therapy that delivers a working SMN1 gene to the motor neurons of people with spinal muscular atrophy (SMA) Type 1. This study will evaluate the safety, tolerability and efficacy of GB221 in two groups: 1. participants aged from 2 weeks to younger than 12 months presenting with symptoms of SMA Type 1 who have never received a treatment OR are receiving the drug risdiplam 2. participants aged from 2 weeks to younger than 5 months who are at risk of developing SMA Type 1 (presymptomatic) and have never received treatment OR are receiving the drug risdiplam.

This description comes directly from the study's public registry record.

Talk to the study team

Denise Reilly  ·  267-718-7654  ·  clinical_studies@gemmabiotx.com

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital de Clínicas de Porto AlegrePorto Alegre, Rio Grande do Sul, BrazilRecruiting

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Source record: clinicaltrials.gov/study/NCT07070999