Actively Recruiting
Clinical Study to Evaluate XS411 in Treatment of Early-onset Parkinson's Disease
Led by XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. · Updated on 2025-12-29
90
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a Phase I/II clinical study to evaluate the safety, tolerability, and efficacy of XS411 in the treatment of EOPD. The study consists of two phases: Phase I and Phase II. Phase I study is planned to be conducted in patients with EOPD, using a single-arm, open-label, traditional " 3+3 " dose-escalation design, aiming to investigate the safety, tolerability and preliminary efficacy of XS411 in the treatment of EOPD and to determine the RP2D. Phase I study enrolls 6-12 patients with EOPD. Two dose cohorts (3-6 patients/dose cohort) are planned: 9×10⁶ cells /patient and 1.8 ×10⁷ cells /patient. Each participant will receive a single injection of XS411. Each participant in each dose cohort will be observed for at least 28 days after dosing . If no DLTs occur and the investigator has no other safety concerns for that participant, the next participant in that dose cohort will be enrolled. Phase II study is planned for patients with EOPD, using a randomized, double-blind, sham-controlled, parallel-group design . The study will investigate the efficacy and safety of XS411 in the treatment of EOPD . Phase II study currently plans to enroll 81 patients with EOPD. The patients will be randomly assigned in a 2:1 ratio to either the experimental or control group. Participants in the experimental group will receive a single injection of XS411 in combination with an immunosuppressant at the RP2D determined during the Phase I dose-escalation phase (which may be adjusted based on the Phase II study results). The control group will receive a sham procedure in combination with an immunosuppressant sham.
CONDITIONS
Official Title
Clinical Study to Evaluate XS411 in Treatment of Early-onset Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of Parkinson's disease onset between 18 and 50 years
- Age at enrollment between 18 and 70 years, any gender
- Diagnosed with early-onset Parkinson's disease meeting specific clinical criteria
- Disease duration of 5 years or more
- Modified Hoehn-Yahr grade in off-phase between 3 and 4 (Phase I) or 2 and 4 (Phase II), and on-phase grade 3 or less
- Off-period MDS-UPDRS-III motor score greater than 30
- Positive response to L-dopa stress test
- Unable to control motor fluctuations with stable medication doses
- Stable anti-Parkinson's drug doses for at least 4 weeks before treatment
- Suitable for surgical anesthesia and brain imaging
- Agree to postpone other neurosurgeries until 24-month follow-up completion
- Agree not to participate in other clinical studies during 24 months after dosing
- Understand and voluntarily consent to study procedures
You will not qualify if you...
- Having non-primary Parkinson's disease or Parkinson's superimposed syndromes
- Experiencing severe disabling dyskinesia or widely fluctuating symptoms in late-stage Parkinson's disease
- Prior brain surgeries such as neuronucleotomy, deep brain stimulation, or other neurosurgeries
- Currently receiving treatments like L-dopa intestinal infusion, apomorphine injection, or continuous anti-Parkinson's drug infusions
- Recent use of botulinum toxin, phenol, baclofen injections, or interventions for dystonia or spasticity within 6 months
- Long-term use of glucocorticoids or immunosuppressants within 3 months before screening
- Previous cell therapy or recent electroconvulsive therapy within 30 days
- Vaccination within 3 months before screening for COVID-19 or other specified vaccines
- History of mental illness, severe suicidal ideation, active epilepsy, or severe cognitive impairment
- Severe anxiety or brain injuries increasing surgical risk
- Uncontrolled autoimmune diseases or severe cardiovascular, cerebrovascular, or systemic diseases
- Conditions affecting study evaluation such as severe arthritis, stroke sequelae, or recent severe trauma
- Malignant tumors or history of malignancy
- Active bleeding disorders or abnormal coagulation
- Allergies to study drugs
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Inability or unwillingness to use effective contraception or donate biological materials as required
- Participation in other clinical trials or receiving interventions within 1 month before treatment
- Poor compliance or other safety concerns as judged by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
M
Michael LEE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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