Senlang Bio Announces Phase I Clinical Trial Initiation of SENL103 Autologous T-cell Injection for Refractory Generalized Myasthenia Gravis

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that senlangbio's SENL103 Autologous T-cell Injection (S103) for the treatment of refractory generalized myasthenia gravis has initiated an open, single-arm Phase I clinical study. The clinical trial registration number is CTR20253934, with the initial information disclosure date on October 16, 2025.

The drug formulation is an injectable, with a specification of 1e6 - 1e7 cells/ml, 20 ml/bag. The dosage is calculated based on body weight, and the treatment duration consists of a single administration. The primary objective of the first phase of this trial is to evaluate the safety and tolerability of S103 in treating refractory generalized myasthenia gravis, and to determine the maximum tolerated dose or the recommended Phase II dose. The main goal of the second phase is to preliminarily assess the efficacy of S103 in study participants with refractory generalized myasthenia gravis.

SENL103 Autologous T-cell Injection is a biological product indicated for refractory generalized myasthenia gravis. This is an acquired autoimmune disease characterized by impaired neuromuscular junction transmission, primarily manifesting as partial or generalized skeletal muscle weakness and extreme fatigability, with symptoms worsening after activity and improving with rest and treatment using cholinesterase inhibitors. Diagnosis relies on clinical manifestations, pharmacological tests, electrophysiological examinations, and serum antibody detection.

The primary endpoint indicators of this trial include the types and incidence of dose-limiting toxicity within 28 days after the first phase of infusion, the types, frequency, and severity of adverse events within 28 days after infusion; the proportion of study participants with a decrease of ≥2 points in MG-ADL/QMG from baseline to 3 months after the second phase of infusion. Secondary endpoint indicators include multiple efficacy and safety-related indicators at various time points in the first and second phases, such as changes in MG-ADL/QMG and the incidence of serious adverse events.

Currently, the experiment status is ongoing (not yet recruiting), with a target enrollment of 15 participants.

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Editor: Xiaolang Express