A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease

This is a single-arm, open-label study to evaluate the safety, tolerability, efficacy, pharmacokinetic, pharmacodynamic, and immune response of BBM-P002 within 52 weeks after into the bilateral putamen in Parkinson's disease, as well as the long-term safety and efficacy of BBM-P002 for up to 5 years post injection.

BBM-P002 is an AAV-based gene therapy that delivers a therapeutic gene cassette into putamen for the treatment of Parkinson's Disease.

Inclusion criteria

• 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
• The participants agreed to postpone the neurosurgical procedures related to the indication treatment during the main study phase
• The participants agreed not to participate in any other therapeutic intervention studies during the trial period
• The participants agreed not to receive the vaccine during the main study phase
• From the screening period until at least 52 weeks after dosing, use a reliable contraceptive method
• The participants had good compliance and were able to undergo regular follow-ups. During the follow-up period, they were able to accurately complete the diary cards. Family members, guardians or caregivers could assist the subjects in filling out the diary cards
• Voluntarilyvoluntarily participated in the study and signed the informed consent form

Exclusion criteria

• 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
• Those with severe depression or severe anxiety
• Abnormal liver function
• Abnormal coagulation function
• Abnormalities in infectious disease screening
• Currently undergoing antiviral treatment for hepatitis
• Suffering from unstable or severe diseases in the cardiovascular, respiratory, digestive, nervous, hematological, immune and other systems
• Suffering from malignant tumors or having a history of tumors
• Previous history of severe allergies
• Exclude those who have participated in other clinical trials within the past three months
• Had received gene therapy during the screening period
• Select those who have received stem cell treatment within the past 12 months
• Exclude those who have used other investigational drugs within the past 4 weeks
• During the screening period, if the individual had received live vaccines within the previous 2 months, or had a history of vaccination within the last 30 days, they would be excluded.
• Having a history of alcohol dependence or drug addiction
• Pregnant or lactating female participants
• The situations that were determined by the investigator to be unsuitable for inclusion in the study