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

NCT07195825 | Recruiting Phase 1

• 1 other identifier: BBM003-CLN001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PD

Keywords

PD; gene therapy; Adeno-Associated Virus

Outcome Measures

Primary Outcomes (2)

• 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

  Within 4 weeks

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  To evaluate the safety of BBM-P002 by AEs and SAEs.

  Within 4 weeks

Secondary Outcomes (9)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Within 5 years

• Changes in the titers of neutralizing antibodies and binding antibodies in the recombinant adenovirus capsid of blood

  Within 5 years

• Changes in the results of the cranial MRI scan

  Within 5 years

• Changes from baseline in MDS - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) I/II/III/IV scores

  Within 5 years

• Changes from baseline in the Patient Global Impression of Improvement (PGI-I) scores

  Within 5 years

Study Arms (1)

Arm of BBM-P002

EXPERIMENTAL

Single-dose treatment

Genetic: Injecting BBM-P002 into the bilateral putamen

Interventions

Injecting BBM-P002 into the bilateral putamen GENETIC

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

Arm of BBM-P002

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Xinzhi BioMed Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Study Officials

• Jun Liu, MD

  Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jing Sun, MD

  Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenshu Luo, Ph.D

CONTACT

021-33588288; luowenshu@beliefbiomed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 29, 2025
• Study Start: December 27, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2031
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)