BBM-P002 AAV gene therapy injected into both putamen for Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, single-arm, open-label trial that delivers BBM-P002, an AAV-based gene therapy, into the bilateral putamen using stereotactic injection and then follows participants for 52 weeks for primary safety/tolerability monitoring and up to five years for long-term safety and efficacy. The protocol includes a dose-limiting toxicity observation period and serial assessments of pharmacokinetics, pharmacodynamics, immune response, and motor function. Eligible participants must have idiopathic Parkinson's disease for at least five years, be levodopa-responsive, and be on stable dopaminergic medication during screening. Safety, tolerability, and biomarker signals will guide further development rather than definitive efficacy conclusions at this stage.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants with a diagnosis of Parkinson's disease for ≥ 5 years.
2. The Hoehn-Yahr staging meets the requirements during the OFF periods.
3. The MDS-UPDRS Part III score met the requirements during the OFF periods. the levodopa challenge test was positive
4. During the screening period, participants were required to take the same stable dose of dopamine-releasing drugs (such as levodopa) regularly
5. The participants agreed to postpone the neurosurgical procedures related to the indication treatment during the main study phase
6. The participants agreed not to participate in any other therapeutic intervention studies during the trial period
7. The participants agreed not to receive the vaccine during the main study phase
8. From the screening period until at least 52 weeks after dosing, use a reliable contraceptive method
9. 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
10. Voluntarilyvoluntarily participated in the study and signed the informed consent form

Exclusion Criteria:

1. Atypical or secondary Parkinsonism
2. Have contraindications for surgery or have previously undergone brain surgery
3. The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease
4. Those with severe cognitive impairments
5. Those with severe depression or severe anxiety
6. Abnormal liver function
7. Abnormal coagulation function
8. Abnormalities in infectious disease screening
9. Currently undergoing antiviral treatment for hepatitis
10. Suffering from unstable or severe diseases in the cardiovascular, respiratory, digestive, nervous, hematological, immune and other systems
11. Suffering from malignant tumors or having a history of tumors
12. Previous history of severe allergies
13. Exclude those who have participated in other clinical trials within the past three months
14. Had received gene therapy during the screening period
15. Select those who have received stem cell treatment within the past 12 months
16. Exclude those who have used other investigational drugs within the past 4 weeks
17. 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.
18. Having a history of alcohol dependence or drug addiction
19. Pregnant or lactating female participants
20. The situations that were determined by the investigator to be unsuitable for inclusion in the study

Where it's running

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Jun Liu, MD — Ruijin Hospital
• Study coordinator: Wenshu Luo, Ph.D
• Email: luowenshu@beliefbiomed.com
• Phone: 021-33588288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.