A Phase 1/2a Clinical Study of KL002 in Treatment of Parkinson's Disease
Key facts
- Where
- Houston, Egyesült ÁllamokSee the site
- Phase
- 1/2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Source: NCT07929480, who can take part
Where in Egyesült Államok
- Houston Methodist HospitalHouston, Egyesült ÁllamokNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kanglin Biotechnology (Hangzhou) Co., Ltd.
- Trial code
- NCT07929480
- Record updated
- 2026. november 10.
- Original description
To assess the safety and tolerability of single doses of KL002 over 78 weeks in subjects with Parkinson's disease。Read full original descriptionShow less
A Phase 1/2a, Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KL002, an AAV9 Gene Therapy, in Subjects With Parkinson's Disease
To assess the safety and tolerability of single doses of KL002 over 78 weeks in subjects with Parkinson's disease。
Inclusion: Males or females ≥ 40 and ≤ 75 years old; Diagnosis of Parkinson's disease per UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria; Duration of Parkinson's disease motor symptoms: 3-12 years; Hoehn and Yahr Stage II-IV (as determined in Practically Defined OFF state); The OFF period MDS-UPDRS III score > 30 ， and the percent improvement in MDS-UPDRS III in the levodopa/carbidopa challenge test is ≥ 30%; Must have been on a stable regimen of Parkinson's disease symptomatic therapy for at least 4 weeks prior to KL002 administration, and must remain stable through dosing unless otherwise approved by the Medical Monitor; Must agree to postpone any Parkinson's disease-related neurological surgery, including deep brain stimulation, until after completing the 24-month follow-up; Patient has the ability to understand the purpose and risks of the study and provide written informed consent and authorization to use protected health information in accordance with national and local privacy regulations.
Exclusion: History of previous brain surgery for Parkinson's disease, such as deep brain stimulation or focused ultrasound; Any type of prior gene or cell therapy; The diagnosis of a significant central nervous system (CNS) disease other than Parkinson's disease that may be a cause for the patient's Parkinson's disease symptoms or may confound study objectives; Hypersensitivity or contraindications to corticosteroid use; Atypical Parkinson's disease or secondary Parkinson's disease caused by factors such as chemicals or toxins; Clinically significant abnormalities in laboratory test results at screening; Montreal Cognitive Assessment (MoCA) score of < 24; Hamilton Depression Rating Scale (HAMD) score of > 17; Use of ambroxol within 8 weeks of dosing; Contraindications to general anesthesia; Any factors that may cause the subject to be unable to follow the study protocol, including medical or social factors, or geographical inconvenience.