Expansion Study of ALT001 in Patients With Multiple System Atrophy (NCT07476352) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Expansion Study of ALT001 in Patients With Multiple System Atrophy
China60 participantsStarted 2026-05-06
Plain-language summary
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.
Who can participate
Age range30 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 li…
What they're measuring
1
The incidence of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Day 180±7 after treatment
2
Changes in the unified multiple system atrophy rating scale (UMSARS) part scores, sum of part 1 and 2 scores
Timeframe: Day 15, 45±3, 75±5, and 180±14 after treatment