A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
Recruiting · NCT06897930 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
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 score ≥6 at screening.
8. Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.
9. For lupus nephritis: Diagnosis of proliferative lupus nephritis based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V LN according to the WHO 2003 ISN/RPS classification.
EXCLUSION:
1. Have received prior treatment with CAR T therapy directed at any target.
2. Have received any therapy that is targeted to CD19 and/or BCMA
3. Received allogenic stem cell transplant or autologous stem cell transplant.
4. An active malignancy that is progressing or requires active treatment.
5. Primary immunodeficiency
6. Active viral or bacterial infection
Where it is running
20 locations listed across 11 US states.
- Research Site - San Francisco, California, United States
- Research Site - Stanford, California, United States
- Research Site - Tampa, Florida, United States
- Research Site - Atlanta, Georgia, United States
- Research Site - Chicago, Illinois, United States
- Research Site - Baltimore, Maryland, United States
- Research Site - Bethesda, Maryland, United States
- Research Site - Boston, Massachusetts, United States
- Research Site - St Louis, Missouri, United States
- Research Site - New York, New York, United States
- Research Site - Syracuse, New York, United States
- Research Site - Chapel Hill, North Carolina, United States
- Research Site - Charlotte, North Carolina, United States
- Research Site - Richmond, Virginia, United States
- Research Site - Seattle, Washington, United States
- Research Site - Seattle, Washington, United States
- Research Site - Bristol, United Kingdom
- Research Site - Darlinghurst, Australia
- Research Site - Melbourne, Australia
- Research Site - Toronto, Canada