RecruitingEarly Phase 1NCT07100171

Evaluation of GM101 Injection in Patients With Parkinson's Disease

A Single-Center, Open-Label, Single-Arm Exploratory Study Evaluating GM101 Injection in Patients With Mid-to-Late Stage Parkinson's Disease


Sponsor

Genemagic Biosciences Co., Ltd

Enrollment

10 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to assess the safety of GM101 in participants with Parkinson's disease (PD)


Eligibility

Min Age: 40 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing GM101, a gene therapy delivered by brain surgery, for people with advanced Parkinson's disease whose symptoms are no longer well controlled by medication. The therapy uses a modified virus to deliver genes that may help restore normal brain cell function in the region affected by Parkinson's. **You may be eligible if...** - You are aged 40–70 - You have had Parkinson's disease for 5 or more years - Your symptoms are advanced (Hoehn-Yahr stage 4–5 when medication is worn off) - You have a significant response to levodopa when it works (improvement >30%) - Your symptoms are not well controlled despite optimal medication - You are healthy enough to undergo brain surgery under anesthesia - Your weight is between 40–110 kg and BMI is 18–34 **You may NOT be eligible if...** - You have a form of parkinsonism that is not true Parkinson's disease - You have previously had deep brain stimulation or other brain surgery - You have had a heart attack, severe heart failure, stroke, or brain bleed - You have a history of cancer - You have received previous cell or gene therapy - You have active HIV, hepatitis B, hepatitis C, or tuberculosis - You are pregnant or planning to become pregnant within 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBiological: GM101

Neurosurgical delivery of GM101 to the putamen


Locations(1)

Xiangya Hospital, Central South University

Changsha, China

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NCT07100171


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