Parkinson DiseaseEarly Phase 1NCT05882487
Safety and Efficacy Study of KL002 in the Treatment of Advanced Primary PD
A Early Phase 1 study testing KL002 injection solution in people with Parkinson Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- KL002 injection solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Jiali Pu, Ph.D. contact
China1 site
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: Safety and Efficacy Study of KL002 in the Treatment of Advanced Primary Parkinson's Dissease
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
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- KL002 injection solution
- Keywords
- Parkinson Disease, KL002, Putamen, Stereotactic brain surgery
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KL002 injection solutionGenetic
Neurosurgical delivery of KL002 to the brain
| Study group | Role | What they receive |
|---|---|---|
| KL002 injection solution | Experimental | single dose, neurosurgically infused, bilaterally into the striatum Receives: Genetic: KL002 injection solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events
Safety and Tolerability of KL002 assessed by Treatment Emergent Adverse Events
Measured: Day 0 through month 24
Secondary outcomes (2)
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.
Measured: Day 0 through month 24
PET Scan Imaging
Relationship between KL002 distribution in the brain and change in dopamine expression as indicated in PET imaging.
Measured: Day 0 through month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- R&D Kanglin Biotech
- Responsible party
- Sponsor
- Investigators
- Baorong Zhang, M.D., Principal investigator, The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou, Zhejiang province, China, 310009
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882487
- Sponsor's protocol ID
- 2023-0013
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of KL002 in the Treatment of Advanced Primary Parkinson's Dissease
- ClinicalTrials.gov ID
- NCT05882487
- Acronym / sponsor ID
- 2023-0013
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, KL002, Putamen, Stereotactic brain surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- R&D Kanglin Biotech
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KL002 injection solution | Experimental | Genetic: KL002 injection solutionsingle dose, neurosurgically infused, bilaterally into the striatum |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KL002 injection solutionNeurosurgical delivery of KL002 to the brain | Genetic | KL002 injection solution |
Primary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: Day 0 through month 24
Safety and Tolerability of KL002 assessed by Treatment Emergent Adverse Events
2 secondary outcomes
Parkinson's Symptoms
Time frame: Day 0 through month 24
PET Scan Imaging
Time frame: Day 0 through month 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiali Pu, Ph.D. contact
Baorong Zhang, M.D. principal investigator
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou, Zhejiang province, China, 310009
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing KL002 injection solution in people with Parkinson Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Ruan, M.D. (+86 18858736151, 11818236@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (time frame: Day 0 through month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.