Study identifier:D8313C00001
ClinicalTrials.gov identifier:NCT06897930
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Lupus Erythematosus, Systemic
Phase 1/2
No
Cyclophosphamide, Fludarabine
All
150
Interventional
18 Years - 70 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca
AstraZeneca
-
This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus.
The study will enrol adult participants with refractory Systemic Lupus Erythematosus (SLE) The study will be run in 2 parts; First part is Phase 1b during which the study aims to assess safety and tolerability of AZD0120 in patients in refractory SLE cohorts Second part is Phase 2, during which the study aims to assess safety, tolerability and efficacy of the selected dose, following Phase 1b completion, in patients with refractory SLE
Location
Status
Location
Seattle, WA, United States, 98104
Status
Not yet recruiting
Location
New York, NY, United States, 10032
Status
Recruiting
Location
Syracuse, New York, United States, 13202-2240
Status
Not yet recruiting
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 |
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