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A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE

NCT06897930

RecruitingPhase 1, Phase 2

Sponsor: AstraZeneca

Conditions: Lupus Erythematosus, Systemic

Interventions: AZD0120, Cyclophosphamide, Fludarabine

Countries: United States, Australia, Canada, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (20)
  • San Francisco, California, United States
  • Stanford, California, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Bethesda, Maryland, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • Syracuse, New York, United States
  • Chapel Hill, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Richmond, Virginia, United States
  • Seattle, Washington, United States
  • Seattle, Washington, United States
  • Darlinghurst, Australia
  • Melbourne, Australia
  • Toronto, Canada
  • Bristol, United Kingdom