Expansion Study of ALT001 in Patients With Multiple System Atrophy

Starting soon · Early Phase 1

Conditions studied: Multiple System Atrophy

In brief

This is an open-label, single-center, prospective, single-arm clinical study. The primary objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of ALT001 in the treatment of patients with multiple system atrophy (MSA) in a real-world setting.

Key facts

Study ID

NCT07476352

Run by

yilong Wang

People needed

60

Starts

2026-05-06

Expected to finish

2027-10-30

Last updated by the study team

2026-03-30

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Age between 30 and 75 years inclusive, either sex;
• 2. Clinically established or clinically probable MSA (including both MSA-C and MSA-P subtypes);
• 3. Ability to walk independently or with the aid of a walking device for at least 10 meters;
• 4. Provision of written informed consent.

You may not qualify if…

• 1. Evidence of other central nervous system pathologies on brain MRI at screening suggesting a diagnosis of neurodegenerative diseases other than MSA;
• 2. Other significant pathological findings on brain MRI at screening, including but not limited to: cerebral hemorrhage, acute cerebral infarction, aneurysm, vascular malformation, infectious lesions, brain tumors, or other space-occupying lesions (meningiomas or arachnoid cysts with a maximum diameter <1 cm do not require exclusion);
• 3. Presence of immune-mediated diseases that are inadequately controlled or require treatment with biologic agents;
• 4. Known history of allergies to biologic agents, such as proteins or cell-based products;
• 5. Receipt of any vaccination within the past 1 month;
• 6. Patients with a prior definitive diagnosis of malignancy or those currently receiving anti-tumor drug therapy;
• 7. Patients with a prior definitive diagnosis of epilepsy or those currently taking anti-epileptic drugs;
• 8. Concurrent severe hepatic insufficiency, renal insufficiency, or severe cardiac insufficiency (severe hepatic insufficiency defined as ALT ≥1.5 times the upper limit of normal or AST ≥1.5 times the upper limit of normal; severe renal insufficiency defined as serum creatinine [CRE] ≥1.5 times the upper limit of normal or estimated glomerular filtration rate [eGFR] <40 mL/min/1.73 m²; severe cardiac insufficiency defined as NYHA class 3-4), or any significant abnormalities on physical examination, vital signs, laboratory tests, or electrocardiogram that, in the investigator's opinion, require further examination or treatment, or may interfere with the study procedures or safety;
• 9. Patients with a history of alcohol or substance abuse, or alcohol or substance dependence within the past 2 years;
• 10. Patients diagnosed with psychiatric disorders according to DSM-V criteria, or those with obvious suicidal intent;
• 11. Patients who are pregnant, lactating, or have the potential to become pregnant, or those planning a pregnancy;
• 12. Inability to comply with follow-up assessments due to other reasons;
• 13. Patients deemed by the investigator to be unsuitable for participation in this study.

Where it is running

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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