Safety and Efficacy Study of KL002 in the Treatment of Advanced Primary PD

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05882487
• Other study ID #: 2023-0013
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yang Ruan, M.D.
• Phone: +86 18858736151
• Email: 11818236[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

9 patients will be enrolled to this open-label dose escalation study to evaluate up to three dose levels of KL002 of three patients each. All patients will receive bilateral intraputaminal injections of KL002 through stereotactic brain surgery. The safety and potential clinical responses to KL002 will be assessed by clinical evaluations of Parkinson's disease, cognitive tests, laboratory blood tests and neuroimaging.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: June 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Genetic:
• KL002 injection solution
Neurosurgical delivery of KL002 to the brain

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events	Safety and Tolerability of KL002 assessed by Treatment Emergent Adverse Events	Day 0 through month 24
Secondary	Parkinson's Symptoms	Effect of KL002 on Parkinson's symptoms as recorded in subject diaries, neurological, motor, and non-motor assessments, quality of life surveys and changes to Parkinson's medications.	Day 0 through month 24
Secondary	PET Scan Imaging	Relationship between KL002 distribution in the brain and change in dopamine expression as indicated in PET imaging.	Day 0 through month 24