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)
AstraZeneca
Summary
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.
Description
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
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
INCLUSION: 1. Males or females aged 18 through 70 years inclusive at the time of consent. 2. Written informed consent in accordance with federal, local, and institutional guidelines. 3. Must be able and willing to adhere to the study visit schedule and other protocol requirements 4. Adequate hepatic, renal, pulmonary, and cardiac function 5. Have a clinical diagnosis of SLE according to the EULAR/ American College of Rheumatology (ACR) 2019 criteria with a positive ANA ≥1:80 and a score ≥10. 6. Have used at least two standard immunosuppressants (including one biological agent). 7. SLEDAI-2K s…
Interventions
- BiologicalAZD0120
Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy..
- DrugCyclophosphamide
Lymphodepletion - specified dose prior to receiving AZD0120
- DrugFludarabine
Lymphodepletion - specified dose prior to receiving AZD0120
Locations (16)
- Research SiteSan Francisco, California
- Research SiteStanford, California
- Research SiteTampa, Florida
- Research SiteAtlanta, Georgia
- Research SiteBethesda, Maryland
- Research SiteBoston, Massachusetts