Tests regulatory T cell injections in people with ALS

Trial details

Who runs it

Novabio Therapeutics

Trial code

NCT06671236

Record updated

25 September 2025

Original description

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).Read full original descriptionShow less

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

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).

Inclusion: -; 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: 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; 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; 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; uncontrolled infection; < 3 drugs do not adequately control hypertension; Documented history of pulmonary embolism within 6 months of 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; History of clinically significant tumor, liver or kidney disease, or other uncontrolled disease; Other conditions that the investigator considers unsuitable for enrollment; -; Subjects with any of the following cannot be enrolled in this study:; 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; presence of a feeding tube; Subjects who, in the opinion of the investigator, are at significant risk of suicide.

ClinicalTrials.gov NCT06671236