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Gene Therapy Trial Report

Summary

A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of BBM-D101 in the Treatment of Duchenne Muscular Dystrophy.

NCTID NCT07058662 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Duchenne Muscular Dystrophy (DMD)
Disease Ontology Term DOID:11723
Compound Name BBM-D101
Sponsor Belief BioMed (Beijing) Co., Ltd
Funder Type Industry
Recruitment Status
Enrollment Count 9 (ESTIMATED)
Results Posted Not Available

Therapy Information

Target Gene/Variant Undisclosed
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Undisclosed
Route of Administration Intravenous
Drug Product Type Viral vector
Target Tissue/Cell Undisclosed
Delivery System Viral transduction
Vector Type AAV
Editor Type none
Dose 1 Undisclosed dose
Dose 2
Dose 3
Dose 4
Dose 5

Study Record Dates

Current Stage Phase1, Phase2
Submit Date 2025-07-01
Completion Date 2031-06-30
Last Update 2025-12-04

Participation Criteria

Eligible Age 4 Years - 9 Years
Standard Ages Child
Sexes Eligible for Study MALE

Locations

No.of Trial Sites 1
Locations China

Regulatory Information

Has US IND True
FDA Designations Orphan Drug Designation, Rare Pediatric Disease Designation
Recent Updates IND cleared January 2025

Resources/Links

News and Press Releases
Protocol
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