Safety and Efficacy Study of Parkinson's Disease Gene Therapy Drug (BBM-P002)

NCT05822739 ↗

Phase 0 Completed 10 enrolled Xiangya Hospital of Central South University

NaSingle-groupOpen-labelTreatment

Summary

Safety and Efficacy Study of BBM-P002 in participants with primary advanced Parkinson's disease

Timeline

Start: 2023-04-14
Primary completion: 2025-10-30
Completion: 2025-10-30

Outcome

Met primary endpoint

paper The trial achieved its primary outcome, as BBM-P002 demonstrated a favorable safety and tolerability profile within 12 months post-treatment. PMID 42271071 ↗

Publications

Niu M, Guo J, Yang Y, Xu Q, Cheng C, Li H, Luo N, Zhou H, Zhang P, Li Y, Wang N, Wang C, Li D, Lin Z, Huang P, Yang Z, Yang Z, Song Y, Zheng J, Jiang W, Du Z, Qi Y, Peng H, Tan Y, Hu X, Xiao X, Shen L, Lin J, Liu J. Dual-target gene therapy in Parkinson's disease: a multicenter phase 1 trial. Nat Med. 2026 Jun 10. doi: 10.1038/s41591-026-04436-0. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BBM-P002	Gene therapy (AAV / viral vector)	4e+11 vg	Other
Subject	BBM-P002	Gene therapy (AAV / viral vector)	6e+11 vg	Other
Subject	BBM-P002	Gene therapy (AAV / viral vector)	1e+12 vg	Other
Subject	BBM-P002	Gene therapy (AAV / viral vector)	1.2e+12 vg	Other