NCT07314567

ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus （SLE）

An Open Label, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (SLE)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment in subjects with Relapsed/Refractory Systemic lupus erythematosus (SLE)

Conditions

• System Lupus Erythematosus(SLE)

Interventions

Type	Name	Description
DRUG	ACE1831	ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
DRUG	Lymphodepleting chemotherapy	Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-10-30
• Completion: 2027-12-31
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: China