NCT07058662 A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of BBM-D101 in the Treatment of Duchenne Muscular Dystrophy.
| NCT ID | NCT07058662 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Belief BioMed (Beijing) Co., Ltd |
| Condition | DMD |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2025-07-31 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 9 participants in total. It began in 2025-07-31 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and efficacy of BBM-D101 to treat participants with Duchenne Muscular Dystrophy.
Eligibility Criteria
Inclusion Criteria: 1. The Participants and/or his legal guardian must fully understand the purpose, nature, methods, and potential risks of the study, and sign a written informed consent form. 2. Ambulatory male subjects aged 4 years and above but under 9 years (4 years ≤ age \< 9 years). 3. Any mutation in the DMD gene confirmed by genetic testing 4. Serum creatine kinase (CK) during the screening period meets the study requirements. 5. Receiving stable, standard-dose glucocorticoids before screening. 6. The subject's AAV capsid antibodies meet the clinical trial requirements. 7. Able to cooperate with motor function assessment, MRI, and muscle biopsy as required by the study. 8. Laboratory test results during the screening period and at baseline meet the standards. 9. The subject and/or his legal guardian must fully understand the study procedures, be willing to actively cooperate, commit to high compliance with the protocol, and ensure that the subject attends all scheduled visits. Exclusion Criteria: 1. Positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV-DNA) ≥ 1000 U/mL, hepatitis C virus ribonucleic acid (HCV-RNA) positive, human immunodeficiency virus (HIV) positive, or positive for Treponema pallidum antibodies. 2. Currently receiving antiviral therapy for hepatitis B, hepatitis C, HIV, etc. 3. The investigator deems the subject has severe behavioral or cognitive disorders that may hinder participation in this study. 4. Poorly controlled asthma, or Duchenne Muscular Dystrophy (DMD) leading to significant decline in lung function, or recurrent infectious pneumonia that the investigator considers may affect respiratory function. 5. Left ventricular ejection fraction (LVEF) \< 50% or New York Heart Association (NYHA) cardiac function class ≥ III. 6. Severe or persistent arrhythmias (such as atrial fibrillation, frequent ventricular premature beats, ventricular bigeminy, ventricular trigeminy, severe bundle branch block, etc.), and congenital heart disease that is evaluated by the investigator as unsuitable for participation in this study. 7. Any changes in preventive/cardiomyopathy treatment (initiation of treatment, drug changes, dosing regimen changes, treatment interruption, termination, or restart) within 1 month before the infusion of the study drug. 8. History of liver diseases such as portal hypertension, splenomegaly, hepatic encephalopathy, liver fibrosis ≥ stage 3, or hepatic nodules/cysts found by ultrasound during screening, or elevated alpha-fetoprotein with clinical significance as determined by the investigator. 9. Severe infection (such as pneumonia, pyelonephritis, or meningitis) within 4 weeks before the treatment visit (enrollment may be postponed). 10. History of gene therapy or cell therapy (such as stem cell transplantation). 11. History of or current presence of autoimmune diseases, severe renal, gastrointestinal, neurological, or coagulation disorders, malignant tumors, or other diseases. 12. Other diseases that the investigator deems unsuitable for participation in this study.
Contact & Investigator
Yi Dai, MD
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT07058662 clinical trial?
This trial is open to male participants only, aged 4 Years or older, up to 9 Years, studying DMD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07058662 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07058662 currently recruiting?
Yes, NCT07058662 is actively recruiting participants. Contact the research team at huhanyang@beliefbiomed.com for enrollment information.
Where is the NCT07058662 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07058662 clinical trial?
NCT07058662 is sponsored by Belief BioMed (Beijing) Co., Ltd. The principal investigator is Yi Dai, MD at Peking Union Medical College Hospital. The trial plans to enroll 9 participants.