ZR001 Chemogenetics Gene Therapy Study in Patients With Parkinson's Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-70
SponsorQianfoshan Hospital
About this trial
This study aims to evaluate the safety, tolerability, and preliminary efficacy of ZR001, a novel chemogenetic gene therapy product, in patients with moderately advanced Parkinson's disease (PD). ZR001 is administered via stereotactic injection into the bilateral substantia nigra, followed by postoperative ultra-low-dose clozapine to activate the transduced direct pathway, with the goal of improving motor symptoms of Parkinson's disease.
Eligibility criteria
Qualifiers
Age ≥40 and ≤70 years (at the time of signing the informed consent), any gender.
Diagnosed with Parkinson's disease according to the Diagnostic Criteria for Parkinson's Disease in China (2016 edition).
Modified Hoehn & Yahr stage between 2.5 and 4.
History of Parkinson's disease for at least 5 years but less than 15 years.
Disqualifiers
Have participated in or are currently participating in other clinical studies of PD drugs or other AAV gene therapy or cell therapy.
Presence of other severe psychiatric disorders (e.g., severe depression, schizophrenia, etc.).
Previous adverse reactions to clozapine, such as agranulocytosis or severe neutropenia.
Participants with known allergic constitution, including allergy or hypersensitivity to clozapine, prednisone acetate, other glucocorticoids, their excipients, or local anesthetics.
Trial design
Treatments tested in this trial
- ZR001
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Qianfoshan Hospital
Lead sponsor
Shenzhen Loongen Biotechnology Co., Ltd.
Collaborator
Source ClinicalTrials.gov