NCT06688799

Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases

A Single-Center, Open-Label, Non-Randomized, Single-Arm Clinical Study on the Treatment of Refractory Autoimmune Diseases With CD19-CAR T Cells

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the safety and effi cacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases.

Detailed description

This is a single-center, open-label, non-randomized, Phase I/II trial. Patients with Refractory Autoimmune Diseases will receive CD19 CAR T cells. The primary objective is to learn about the safety and tolerability of CD19 CAR T cell therapy in subjects with Refractory Autoimmune Diseases and to determine the optimal biological dose (OBD) and recommend phase 2 dose (RP2D) in phase I and to learn about the efficacy CD19 CAR T-cell therapy in patients with Refractory Autoimmune Diseases in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 28 days after CD19 CAR T-cell infusion in phase I and overall response rate (ORR) in phase II. A total number of 18 subjects will be enrolled.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	CD19 CAR-T cells	Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.

Timeline

• Start date: 2024-11-23
• Primary completion: 2026-03-01
• Completion: 2026-12-01
• First posted: 2024-11-14
• Last updated: 2026-03-10

Locations

1 site across 1 country: China