A study to investigate the safety, tolerability, and efficacy of AZD0120 in adults with Refractory SLE
Study identifier:D8313C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Will Be Recruiting
Official Title
A Phase 1b/2 Study of AZD0120, a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects with Refractory Systemic Lupus Erythematosus (SLE)
Medical condition
Lupus Erythematosus, Systemic
Phase
Phase 1/2
Healthy volunteers
No
Study drug
Cyclophosphamide, Fludarabine
Sex
All
Estimated Enrollment
150
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 25 Mar 2025
Estimated Primary Completion Date: 01 May 2029
Estimated Study Completion Date: 01 May 2029
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD0120 Single dose of AZD0120 | Biological/Vaccine: AZD0120 Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy.. Other Name: GC012F |
