The purpose of the study is to evaluate the safety and tolerability of BBM-P002 for stereotactic injection to treat participants with idiopathic Parkinson's Disease (PD) during the dose-limiting toxicity (DLT) observation period.
Participants with a diagnosis of Parkinson's disease for ≥ 5 years.
The Hoehn-Yahr staging meets the requirements during the OFF periods.
The MDS-UPDRS Part III score met the requirements during the OFF periods. the levodopa challenge test was positive
During the screening period, participants were required to take the same stable dose of dopamine-releasing drugs (such as levodopa) regularly
Atypical or secondary Parkinsonism
Have contraindications for surgery or have previously undergone brain surgery
The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease
Those with severe cognitive impairments
Single group
Injecting BBM-P002 into the bilateral putamen
GeneticBBM-P002 is an AAV-based gene therapy that delivers a therapeutic gene cassette into putamen for the treatment of Parkinson's Disease
Incidence of dose limiting toxicity (DLT) events
To evaluate the rate of incidence of DLT events determined by the Safety Data Review Committee (SRC) in DLT observation period after injecting BBM-P002
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the safety of BBM-P002 by AEs and SAEs.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To assess the long-term safety of BBM-P002 by AEs and SAEs
Changes in the titers of neutralizing antibodies and binding antibodies in the recombinant adenovirus capsid of blood
To assess changes in the titers of neutralizing antibodies and binding antibodies in the recombinant adenovirus capsid of blood after injecting BBM-P002
Changes in the results of the cranial MRI scan
To assess changes in the results of the cranial MRI scan after injecting BBM-P002
Changes from baseline in MDS - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) I/II/III/IV scores
The theoretical maximum total score of the MDS-UPDRS is 272 points. It comprehensively assesses the health status of Parkinson's disease patients by evaluating four major aspects: non-motor symptoms, daily activities, motor function, and motor complications. The higher the score, the more severe the condition
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