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Safety and Efficacy Study of KL002 in the Treatment of Advanced Primary PD | Clinical Trials | Clareo Health

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

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

NCT05882487•Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Detailed 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.

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

June 1, 2023

Primary Completion Date

April 30, 2026

Completion Date

June 30, 2026

Last Updated

May 31, 2023

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

KL002 injection solution

GENETIC

Contacts

Yang Ruan, M.D.

CONTACT

+86 18858736151 11818236@zju.edu.cn

Jiali Pu, Ph.D.

CONTACT

jialipu@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 31, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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