RecruitingEarly Phase 1

The Study of Safety and Preliminary Efficacy of Aleeto in Patients With MultIple System Atrophy

China20 participantsStarted 2025-05-31

Plain-language summary

This is a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study. At the end of the PROBE study, patients who have completed the study may opt to enter the open-label extension (OLE) study. The objective of the study is to evaluate the safety, tolerability and potential preliminary efficacy of Aleeto in the treatment of patients with multiple system atrophy (MSA).

Who can participate

Age range30 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓.30 years ≤ 75 years of age, regardless of sex; 2.Clinically confirmed or clinically probable MSA-P; 3.Poor response to levodopa; 4.MSA-related motor symptom onset ≤5 years at first visit; 5.Walking ≥10 meters independently or with a walking aid; 6.Expected survival of ≥1 year, as determined by the investigator; 7.Signed informed consent.

Exclusion criteria

✕. Head MRI at screening showing evidence of other CNS lesions consistent with a diagnosis of neurodegenerative disease other than MSA;
✕. Patients with MMSE scores indicative of dementia prior to enrolment (≤17 points for illiterate individuals, ≤20 points for individuals with elementary school education, ≤24 points for individuals with junior high school education or higher) or those with a prior confirmed diagnosis of dementia;
✕. Head MRI at screening showing other significant pathological findings including but not limited to: cerebral hemorrhage, acute phase of cerebral infarction, aneurysm, vascular malformation, infectious lesion, brain tumor or other space-occupying lesion (meningiomas or arachnoid cysts with a maximum diameter of \<1 cm need not be excluded);
✕. Presence of immune disorders that are inadequately controlled or require treatment with biological agents;
✕. Known history of allergy to biological agents such as proteins and cell products;
✕. Patients who have received any vaccination within 1 month;
✕. Patients with pre-existing, clearly diagnosed malignant tumor or being treated with anti-tumor drugs;
✕. Patients with a history of clearly diagnosed epilepsy or taking antiepileptic drugs;

What they're measuring

The incidence of investigator-reported adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Day 90±7 after randomization

The incidence of changes in clinical laboratory test parameters, changes in vital signs, neurological examination abnormalities and ECG abnormalities

Timeframe: Day 90±7 after randomization

Trial details

NCT IDNCT06765733

SponsorBeijing Tiantan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Weiqi Chen, M.D.

8615652813380 weiqichen@aliyun.com

View on ClinicalTrials.gov More Multiple System Atrophy - Parkinsonian Subtype (MSA-P) trials

Plain-language summary

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

✓.30 years ≤ 75 years of age, regardless of sex; 2.Clinically confirmed or clinically probable MSA-P; 3.Poor response to levodopa; 4.MSA-related motor symptom onset ≤5 years at first visit; 5.Walking ≥10 meters independently or with a walking aid; 6.Expected survival of ≥1 year, as determined by the investigator; 7.Signed informed consent.

Exclusion criteria

✕. Head MRI at screening showing evidence of other CNS lesions consistent with a diagnosis of neurodegenerative disease other than MSA;
✕. Patients with MMSE scores indicative of dementia prior to enrolment (≤17 points for illiterate individuals, ≤20 points for individuals with elementary school education, ≤24 points for individuals with junior high school education or higher) or those with a prior confirmed diagnosis of dementia;
✕. Head MRI at screening showing other significant pathological findings including but not limited to: cerebral hemorrhage, acute phase of cerebral infarction, aneurysm, vascular malformation, infectious lesion, brain tumor or other space-occupying lesion (meningiomas or arachnoid cysts with a maximum diameter of \<1 cm need not be excluded);
✕. Presence of immune disorders that are inadequately controlled or require treatment with biological agents;
✕. Known history of allergy to biological agents such as proteins and cell products;
✕. Patients who have received any vaccination within 1 month;
✕. Patients with pre-existing, clearly diagnosed malignant tumor or being treated with anti-tumor drugs;
✕. Patients with a history of clearly diagnosed epilepsy or taking antiepileptic drugs;

What they're measuring

The incidence of investigator-reported adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Day 90±7 after randomization

The incidence of changes in clinical laboratory test parameters, changes in vital signs, neurological examination abnormalities and ECG abnormalities

Timeframe: Day 90±7 after randomization