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

NCT05882487 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2023-0013
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Parkinson Disease

Keywords

Parkinson Disease; KL002; Putamen; Stereotactic brain surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events

  Safety and Tolerability of KL002 assessed by Treatment Emergent Adverse Events

  Day 0 through month 24

Secondary Outcomes (2)

• Parkinson's Symptoms

  Day 0 through month 24

• PET Scan Imaging

  Day 0 through month 24

Study Arms (1)

KL002 injection solution

EXPERIMENTAL

single dose, neurosurgically infused, bilaterally into the striatum

Genetic: KL002 injection solution

Interventions

KL002 injection solution GENETIC

Neurosurgical delivery of KL002 to the brain

KL002 injection solution

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior brain surgery including deep brain stimulation or abnormal brain imaging.
• Presence of depression as measured by Hamilton Depression Scale ≥20
• History of brain injury or central nervous system infection.
• Cognitive impairment score\<26 on MoCA and ≤ 20 on MMSE dementia scale
• Evidence of significant medical or psychosis, such as dementia, psychosis, and a history of drug abuse
• 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.
• Prior gene therapy.
• Chronic immunosuppressive therapy, including chronic steroids, immunotherapy, cytotoxic therapy and chemotherapy
• Any other conditions that the investigator believed unsuitable for participation in this study.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• R&D Kanglin Biotech: collaborator

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Baorong Zhang, M.D.

  The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou, Zhejiang province, China, 310009

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Ruan, M.D.

CONTACT

+86 18858736151; 11818236@zju.edu.cn

Jiali Pu, Ph.D.

CONTACT

jialipu@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)