RecruitingPhase 1NCT06671236

Clinical Study of Regulatory T Cells (Tregs) in the Treatment of Neurodegenerative Diseases

An Open, Single-Arm, Multi-Center Clinical Study to Evaluate the Safety and Tolerability of Regulatory T Cells (Tregs) In the Treatment of Neurodegenerative Diseases

Sponsor

Novabio Therapeutics

Enrollment

12 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Amyotrophic Lateral Sclerosis(ALS)

Summary

An open, multi- center phase Ⅰ clinical study evaluating the safety and efficacy of autologous human polyclonal regulatory T cell injection (NP001 cell injection) in patients with Neurodegenerative diseases (ALS).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria14

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Patients must meet all of the following criteria to be eligible for enrollment in this study:
Male or female patients aged 18 to 70 years;
According to current international diagnostic criteria:
ALS: defined by the Gold Coast Diagnostic Criteria (Shefner, 2020) as having a diagnosis of sporadic or familial amyotrophic lateral sclerosis (ALS), diagnosed as a probable, probable, or definite patient with laboratory support according to the World Federation of Neurology El Escorial criteria;
If there is a stable dose for more than one month prior to study entry. For example, patients with ALS can continue treatment with riluzole (Rilutek®) and/or edaravone (Radicava®);
Patients must have \> two weeks after the end of major surgery and after the completion of participation in other research trials;
Patients must have recovered from clinical toxicity (CTCAE \[5th Edition\] toxicity values have resolved to \< 2);
Serum creatinine less than or equal to 2.0 mg/dL;
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal;
Bilirubin \< 1.5 (except Gilbert's disease);
Lung slow vital capacity (SVC) \> 70% of predicted normal;
No history of abnormal bleeding tendency;
Informed consent must be obtained prior to performing any study-related procedures that are not part of standard medical care, with the understanding that the participant may withdraw from the study without influence for the future medical care.

Exclusion Criteria18

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Subjects with any of the following cannot be enrolled in this study:
uncontrolled infection;
\< 3 drugs do not adequately control hypertension;
Documented history of pulmonary embolism within 6 months of enrollment;
Clinically significant cardiology, defined as: myocardial infarction, NYHA-graded class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, or ECG evidence of acute ischemia or abnormal conduction system within 6 months prior to enrollment;
Patients with a history of coronary artery bypass grafting or angioplasty will be evaluated by cardiology and considered on a case-by-case basis;
Seropositive for HIV, hepatitis B or hepatitis C;
Pregnant or lactating patients;
Patients of childbearing potential or males with partners of childbearing potential who are unwilling to use contraception;
Participation in any other interventional study;
Treatment with another investigational drug, biologic, or device within 30 days or 5 half-lives (whichever is longer) of the screening period. Patient participation in observational/non-interventional clinical studies will be discussed with the Medical Monitor;
Prior treatment with ALS gene or cell therapy;
History of clinically significant tumor, liver or kidney disease, or other uncontrolled disease;
presence of a feeding tube;
Current use of antipsychotics, antiepileptic drugs (except benzodiazepines, gabapentin, pre-Bahrain) or class 1 (e.g., flecainide) or class 3 (e.g., amiodarone) antiarrhythmic drugs;
Subjects who, in the opinion of the investigator, are at significant risk of suicide;
Other conditions that the investigator considers unsuitable for enrollment.

Interventions

BIOLOGICALAutologous Human Polyclonal Regulatory T Cells Injection (NP001 Cell Injection)

Regulatory T cell therapy, intrathecal injection

Locations(1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

View Full Details on ClinicalTrials.gov

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NCT06671236

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