ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
NCT07314567 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2026-01-02
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
- DRUG
-
Lymphodepleting chemotherapy
Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.
- DRUG
-
ACE1831
ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Sponsors & Collaborators
-
Tongji Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-01
- Primary Completion
- 2027-10-30
- Completion
- 2027-12-31
Countries
- China
Study Locations
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