A Phase 1/2 interventional study of Injecting KL002 into the bilateral putamen in Parkinson's Disease (PD) and PD, sponsored by Kanglin Biotechnology (Hangzhou) Co., Ltd.. Not yet recruiting at 1 site in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Kanglin Biotechnology (Hangzhou) Co., Ltd. · Phase 1/2, Interventional, and Treatment
To assess the safety and tolerability of single doses of KL002 over 78 weeks in subjects with Parkinson's disease。
This is an open-label, non-randomized, phase 1/2a single ascending dose study, consisting of Dose Escalation and Dose Expansion parts, to evaluate the safety, tolerability, and efficacy of KL002 in patients with Parkinson's disease. Eligible subjects will enter the dose escalation part of the study, receive a single stereotactic intraputaminal administration of KL002, and be followed for 18 months in the core study and up to 5 years total in long-term follow-up (LTFU) with safety and efficacy assessments.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 12 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Kanglin Biotechnology (Hangzhou) Co., Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Putamen stereotactic injection of low dose of KL002
Genetic: Injecting KL002 into the bilateral putamen
Putamen stereotactic injection of high dose KL002
Genetic: Injecting KL002 into the bilateral putamen
KL002 is a recombinant adeno-associated virus (rAAV9) vector carrying TH, GCH1, and AADC genes
Adverse event (AE) incidence
To evaluate AEs by CTCAE 6.0
Time frame: From administration of KL002 to the end of the follow-up within 78 weeks
Incidence of procedure or treatment-emergent safety findings
Assessed by brain MRI
Time frame: within 78 weeks
Changes in mood
Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS). The range of crisis assessment scores is 1-10 points, with higher scores indicating higher suicidal tendencies.
Time frame: within 78 weeks
Change from baseline in Parkinson's disease medication dosage
Expressed as levodopa equivalent daily dose (LEDD)
Time frame: within 78 weeks
Motor function
Determined byMDS-UPDRS III. The highest score is 56 points, and the lower the score, the better the recovery situation.
Time frame: within 78 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kanglin Biotechnology (Hangzhou) Co., Ltd.