NCT07261345

Allogeneic Anti-CD19/BCMA CAR-T for Refractory Graves' Disease

The Safety and Efficacy of Allogenic Anti-CD19/BCMA CAR-T Cell Therapy for Refractory Graves' Disease

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Graves' disease is an autoimmune thyroid disorder in which autoantibodies against the thyroid-stimulating hormone receptor (TRAb) lead to excessive thyroid hormone production and systemic complications, as well as thyroid eye disease and pretibial myxedema in some cases. Patients with refractory Graves' disease often fail to achieve durable remission despite prolonged antithyroid medication. This study aims to evaluate the safety and efficacy of RD06-05, an allogeneic dual CD19/BCMA CAR-T therapy, in participants with refractory Graves' disease, and will provide preliminary evidence on whether dual-targeting CAR-T therapy can induce sustained remission of refractory Graves' disease.

Conditions

• Graves' Disease

Interventions

Type	Name	Description
BIOLOGICAL	allogenic anti-CD19/BCMA CAR-T	Participants will receive a single infusion of allogenic anti-CD19/BCMA CAR-T (RD06-05).

Timeline

• Start date: 2025-12-19
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-12-03
• Last updated: 2026-01-05

Locations

1 site across 1 country: China