Study of CT1195E CAR-T Cell Therapy for Moderate to Severe Refractory Systemic Lupus Erythematosus Evaluating Safety, Effectiveness, and Cell Metabolism in Adults

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and cell metabolism of ct1195e cells in adults with moderate to severe refractory Systemic Lupus Erythematosus SLE. This early phase 1 study explores dose levels and cellular responses to better understand this therapys potential. The trial aims to find the maximum tolerated dose and assess side effects and disease activity over time. Participants receive infusions of CT1195E CAR-T cells in a two-stage process an initial dose escalation phase with three planned dose levels 3.0 x 108, 4.5 x 108, and 6.0 x 108 cells followed by a dose expansion phase selecting one or more dose groups for further evaluation. Dose decisions are based on safety, tolerance, and cell metabolism, with a 28-day dose-limiting toxicity observation period after infusion. During the study, participants are monitored through assessments of toxicity, adverse events, and SLE disease activity using various clinical scores and biomarker changes. Follow-up includes evaluations at multiple time points up to one year to measure cell gene presence and immune function. Safety data and disease responses guide ongoing treatment decisions and participant management throughout the trial.

A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Dynamics of Universal CD19 / 20 Car-t Cell Injection in Moderate to Severe Refractory Systemic Lupus Erythematosus