NCT06902844

Equecabtagene Autoleucel Injection (Eque-cel) for Relapsed/Refractory Systemic Lupus Erythematosus (SLE)

A Study of Equecabtagene Autoleucel Injection (Eque-cel) in the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of Equecabtagene Autoleucel Injection (Eque-cel) in patients with Relapsed /refractory systemic lupus erythematosus (SLE).

Detailed description

SLE is a chronic diffuse connective tissue disease with unexplained etiology that can involve multiple systems. SLE is considered as an incurable disease and traditional SLE treatment aims at long-term remission. Eque-cel is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), which expressed on both mature B lymphocytes and malignant plasma cells. BCMA CAR-T cells offer another potential therapeutic option to eliminate plasma cells in patients with SLE driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In this study subjects will receive a three-day consecutive lymphodepletion therapy, and 1.0×10\^6 total CAR T cells/kg after enrollment. A follow-up phase will include assessments for safety, efficacy evaluation and pharmacokinetics monitoring. The duration of this trial is about 2-3 years.

Conditions

• Systemic Lupus Erythematosus (SLE)
• Lupus Nephritis (LN)

Interventions

Type	Name	Description
DRUG	Equecabtagene Autoleucel Injection	dosage form: injection, dosage: 1.0×10\^6 CAR-T/kg, frequency: single dose.

Timeline

• Start date: 2025-04-05
• Primary completion: 2027-10-31
• Completion: 2028-01-10
• First posted: 2025-03-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: China