Shanghai Saierxin Launches Phase I/IIa Clinical Trial of Autologous Polyclonal Regulatory T Cell Injection (NP001) for Amyotrophic Lateral Sclerosis

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that the Phase I/IIa clinical study on the safety and efficacy of autologous polyclonal regulatory T cells (NP001 cell injection) for treating amyotrophic lateral sclerosis, conducted by Shanghai Saierxin Biomedical Technology Co., Ltd. (NOVABIOTX), has been initiated. The clinical trial registration number is CTR20253607, with the initial information disclosure date on September 10, 2025.

The drug formulation is an injectable, administered via intrathecal infusion. Single-dose administration during the SAD phase, repeated dosing in both the MAD and Phase IIa trials, once monthly for a total of three doses. The product must be used within 2 hours after reconstitution. The primary objective of this trial is to evaluate the safety and tolerability of NP001 cell injection in ALS subjects; secondary objectives include assessing its impact on disease status, the survival duration of ALS subjects, and the effects on immune system parameters in blood and cerebrospinal fluid.

Autologous Polyclonal Regulatory T-Cell Injection is a biological product, indicated for Amyotrophic Lateral Sclerosis (ALS). ALS is a neurodegenerative disease that affects motor neurons in the brain and spinal cord, leading to muscle weakness and atrophy, and patients gradually lose the ability to move, speak, swallow, and breathe. Diagnosis relies on clinical manifestations, electromyography, etc.

The primary endpoint indicators of this trial include the types, severity, and incidence of adverse events and serious adverse events; Phase I also includes the incidence and characteristics of dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of NP001 cell injection. Secondary endpoint indicators include the impact of NP001 cell injection on disease status, survival period, and changes in immune system parameters in blood and cerebrospinal fluid.

Currently, the experiment status is ongoing (not yet recruiting), with a target enrollment of 45 participants.

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Editor: Xiaolang Express