NCT07167537

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

An Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Allogeneic CAR-T Cell Therapy (OL-CD19-GDT) in the Treatment of Relapsed/Refractory Autoimmune Diseases

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-CD19-GDT in relapsed/refractory autoimmune diseases.

Detailed description

This is an open-label, single-arm, clinical study to evaluate the efficacy and safety of CAR-T therapy OL-CD19-GDT in the treatment of Relapsed/ Refractory Autoimmune Diseases such as SSc and pSS.

Conditions

• Systemic Sclerosis (SSc)
• Primary Sjogren's Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	OL-CD19-GDT	OL-CD19-GDT will be given through IV bolus with ascending dose levels to determine the RDE and RP2D as specified in the protocol

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

1 site across 1 country: China