Phase 2 Muscular Dystrophy Trial, Recruiting NCT07429240 Sponsor: Precision BioSciences, Inc. Condition: Muscular Dystrophy
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Phase 2 Muscular Dystrophy Trial, Recruiting

NCT07429240
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Boys between 2 and 7 years old (inclusive) at the time of consent
  • Boys who have a confirmed DMD diagnosis through genetic testing, where the specific gene change falls within a region known as exons 45 to 55
  • Boys whose symptoms match what doctors typically see in DMD, as assessed by the trial doctor
  • Boys aged 2 to under 4 years who are able to walk at least 10 metres on their own (without walking aids) and can get up from the floor without someone physically helping them (using the hands-on-knees climbing-up method is fine)
  • Boys aged 4 to 7 years who are able to walk at least 100 metres on their own (without walking aids) and whose score on a standard movement ability test (called the NSAA) falls between 16 and 29
  • Boys who have received the standard childhood vaccinations recommended in their country
  • Boys whose parent(s) or legal guardian(s) are willing and able to give written permission before the trial begins, and where required by local rules, the child also gives agreement
  • Boys and their parent(s) or legal guardian(s) who are willing to take part in a long-term follow-up study after this trial ends

Who may not be able to join:

  • Boys who have previously received any gene therapy, gene editing therapy, or cell-based therapy at any point in their life
  • Boys who have taken part in another experimental treatment or investigational drug study within the 6 months before the trial start date
  • Boys who have used any treatment aimed at increasing dystrophin (a key muscle protein) — including exon-skipping therapies — within 6 months before the scheduled trial start, or who are unwilling to avoid starting or restarting such therapies for at least 5 years after receiving the gene therapy in this trial
  • Boys who are currently enrolled in another clinical trial that involves an active treatment or intervention (observational studies with no treatment are generally acceptable — confirm with trial site)
  • Boys whose blood test shows antibodies against a substance called AAV9 (a component used to deliver the therapy)
  • Boys who have any medical condition that would make it unsafe to receive immune-suppressing medications
  • Boys whose genetic change falls in a different region of the gene (exons 1–44 or exons 56–79) rather than the required region
  • Boys who show signs of heart muscle disease or reduced heart pumping function, specifically a heart measurement called LVEF below 50% on a heart ultrasound scan

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: (800) 593-0346

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Precision BioSciences, Inc.
Registry
ClinicalTrials.gov
Start date
24 April 2026
Est. completion
1 November 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence, severity, and causality of treatment-emergent adverse events and serious adverse events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov