Safety and Efficacy Study of KL002 in the Treatment of Advanced Primary Parkinson's Dissease

Trial ID: NCT05882487

Interventional - Phase 1 - Unknown status

This is a non-randomized, open label, dose-escalation study to evaluate the safety and efficacy of KL002 in the treatment of advanced primary Parkinson's disease. Condition or disease: Parkinson's Disease Intervention/treatment: Drug: KL002 Phase: NA

Conditions

• Parkinson Disease

Interventions

• KL002 injection solution

Eligibility

Inclusion criteria

• 1. Males/females between 40 and 70 years (inclusive)
• 2. Diagnosed with idiopathic Parkinson's disease, Hoehn and Yahr stage 4 and 5
• 3. Disease duration at least 5 years
• 4. MDS UPDRS Part III (total motor) score ≥ 25 and a maximum of 60 in the OFF state
• 5. Good compliance and can complete all follow-up in accordance with the protocol requirements

Exclusion criteria

• 1. Prior brain surgery including deep brain stimulation or abnormal brain imaging.
• 2. Presence of depression as measured by Hamilton Depression Scale ≥20
• 3. History of brain injury or central nervous system infection.
• 4. Cognitive impairment score\<26 on MoCA and ≤ 20 on MMSE dementia scale
• 5. Evidence of significant medical or psychosis, such as dementia, psychosis, and a history of drug abuse
• 6. Atypical or secondary parkinsonism, including but not limited to symptoms believed to be due to trauma, brain tumor, infection, cerebrovascular disease, other neurological disease, or to drugs, chemicals, or toxins.
• 7. Prior gene therapy.
• 8. Chronic immunosuppressive therapy, including chronic steroids, immunotherapy, cytotoxic therapy and chemotherapy
• 9. Any other conditions that the investigator believed unsuitable for participation in this study.

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine, R&D Kanglin Biotech

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows