Tests a gene therapy injected into the brain for Parkinson's disease

Trial details

Who runs it

Shanghai Xinzhi BioMed Co., Ltd.

Trial code

NCT07195825

Record updated

4 August 2026

Original description

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.Read full original descriptionShow less

A Single-arm, Open-label, Single-dose Clinical Study to Evaluate the Safety and Tolerability of BBM-P002 for Stereotactic Bilateral Putamen Injection in the Treatment of Idiopathic Parkinson's Disease

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.

Inclusion: 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: Have contraindications for surgery or have previously undergone brain surgery; Previous history of severe allergies; 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; The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease; 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; Having a history of alcohol dependence or drug addiction; Atypical or secondary Parkinsonism; Those with severe cognitive impairments; Those with severe depression or severe anxiety; Abnormal liver function; Abnormal coagulation function; Exclude those who have participated in other clinical trials within the past three months; Pregnant or lactating female participants; The situations that were determined by the investigator to be unsuitable for inclusion in the study.

ClinicalTrials.gov NCT07195825