Phase 1 Study of OL-CD19-GDT CAR-T Cell Therapy for Adults with Relapsed or Refractory Systemic Sclerosis and Primary Sjogrens Syndrome Evaluating Safety, Tolerability, and Early Effectiveness

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of a CAR-T cell therapy called OL-CD19-GDT in adults with relapsed or refractory autoimmune diseases such as Systemic Sclerosis SSc and Primary Sjogrens Syndrome pSS. This open-label, single-arm clinical study is designed to understand how this investigational treatment behaves in the body and its potential benefits for these conditions. Participants will receive OL-CD19-GDT through an intravenous bolus with ascending dose levels to find the recommended dose for further studies. The study includes one treatment phase with follow-up for up to two years to monitor effects and safety. OL-CD19-GDT administration is preceded by lymphodepletion to prepare the body for treatment. During the study, participants will undergo evaluations for dose-limiting toxicity within 30 days after receiving OL-CD19-GDT and monitoring for treatment-emergent adverse events throughout the study period, up to two years. Researchers will also track overall response rates, pharmacokinetics measures such as maximum concentration and time to maximum concentration of OL-CD19-GDT, serum cytokine levels, immunogenicity, and replication-competent virus levels. Safety and health assessments will be regularly performed to observe participants status over time.

A Study of OL-CD19-GDT in Relapsed/ Refractory Autoimmune Diseases