ALT001 expansion study for people with multiple system atrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an early-phase, open-label, single-arm study conducted at a single center in Beijing. The trial aims to assess safety, tolerability, and preliminary efficacy of ALT001 in adults with MSA in a real-world setting. Eligible participants are adults with clinically established or probable MSA who can walk 10 meters with or without aid. The study will monitor adverse events and provide initial signals of therapeutic activity over a short-term treatment window.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Beijing Tiantan Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Yilong Wang — Beijing Tiantan Hospital, Capital Medical University, Beijing, China
• Study coordinator: Weiqi Chen
• Email: weiqichen@aliyun.com
• Phone: 8615652813380

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.