PDPhase 1NCT07195825
A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease
A Phase 1 study testing Injecting BBM-P002 into the bilateral putamen in people with PD, run by Shanghai Xinzhi BioMed Co., Ltd. at 1 site in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- PD
- What is being tested?
- Injecting BBM-P002 into the bilateral putamen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2025to 30 Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jun Liu, MD, 021-64370045, jly0520@hotmail.com
Jing Sun, MD, 021-34186000, sunjing2@medmail.com.cn
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- PD
- Being tested
- Injecting BBM-P002 into the bilateral putamen
- Keywords
- PD, gene therapy, Adeno-Associated Virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injecting BBM-P002 into the bilateral putamenGenetic
BBM-P002 is an AAV-based gene therapy that delivers a therapeutic gene cassette into putamen for the treatment of Parkinson's Disease
| Study group | Role | What they receive |
|---|---|---|
| Arm of BBM-P002 | Experimental | Single-dose treatment Receives: Genetic: Injecting BBM-P002 into the bilateral putamen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 4 weeks
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the safety of BBM-P002 by AEs and SAEs.
Measured: Within 4 weeks
Secondary outcomes (9)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To assess the long-term safety of BBM-P002 by AEs and SAEs
Measured: Within 5 years
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
Measured: Within 5 years
Changes in the results of the cranial MRI scan
To assess changes in the results of the cranial MRI scan after injecting BBM-P002
Measured: Within 5 years
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
Measured: Within 5 years
Changes from baseline in the Patient Global Impression of Improvement (PGI-I) scores
Choose a number from 1 to 7. The higher the number choosen, the worse the improvement.
Measured: Within 5 years
Changes from baseline in the Clinical Global Impression of Improvement (CGI-I) scores
Choose a number from 1 to 7. The higher the number choosen, the worse the improvement.
Measured: Within 5 years
Changes in the activity levels of gene expression products under18F-dopa PET scanning from baseline [striatum - occipital lobe average radioactivity count ratio]
To assess changes in the activity levels of gene expression products under18F-dopa PET scanning from baseline [striatum - occipital lobe average radioactivity count ratio] after injecting BBM-P002
Measured: Within 5 years
Changes from baseline in daily levodopa dose or equivalent dose of levodopa
To assess changes from baseline in the levodopa dosage or levodopa equivalent dosage after injecting BBM-P002
Measured: Within 5 years
Changes from baseline in the percentage at on time.
To assess changes from baseline in the percentage at on time after injecting BBM-P002
Measured: Within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start27 Dec 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Xinzhi BioMed Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Liu, MD, Principal investigator, Ruijin HospitalJing Sun, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195825
- Sponsor's protocol ID
- BBM003-CLN001
- Status last verified
- Aug 2026
- First submitted
- 10 Sep 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07195825
- Acronym / sponsor ID
- BBM003-CLN001
- Conditions
- PD
- Keywords
- PD, gene therapy, Adeno-Associated Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Xinzhi BioMed Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm of BBM-P002 | Experimental | Genetic: Injecting BBM-P002 into the bilateral putamenSingle-dose treatment |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injecting BBM-P002 into the bilateral putamenBBM-P002 is an AAV-based gene therapy that delivers a therapeutic gene cassette into putamen for the treatment of Parkinson's Disease | Genetic | Arm of BBM-P002 |
Primary outcome
Incidence of dose limiting toxicity (DLT) events
Time frame: Within 4 weeks
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)
Time frame: Within 4 weeks
To evaluate the safety of BBM-P002 by AEs and SAEs.
9 secondary outcomes
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Within 5 years
Changes in the titers of neutralizing antibodies and binding antibodies in the recombinant adenovirus capsid of blood
Time frame: Within 5 years
Changes in the results of the cranial MRI scan
Time frame: Within 5 years
Changes from baseline in MDS - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) I/II/III/IV scores
Time frame: Within 5 years
Changes from baseline in the Patient Global Impression of Improvement (PGI-I) scores
Time frame: Within 5 years
Changes from baseline in the Clinical Global Impression of Improvement (CGI-I) scores
Time frame: Within 5 years
Changes in the activity levels of gene expression products under18F-dopa PET scanning from baseline [striatum - occipital lobe average radioactivity count ratio]
Time frame: Within 5 years
Changes from baseline in daily levodopa dose or equivalent dose of levodopa
Time frame: Within 5 years
Changes from baseline in the percentage at on time.
Time frame: Within 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Liu, MD principal investigator
Ruijin Hospital
Jing Sun, MD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Injecting BBM-P002 into the bilateral putamen in people with PD, run by Shanghai Xinzhi BioMed Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenshu Luo, Ph.D (021-33588288, luowenshu@beliefbiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLT) events (time frame: Within 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.