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

RecruitingPhase 1, Phase 2Ages 18 Years - 70 YearsAllAstraZeneca
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (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 โ‰ฅ1:80 and a score โ‰ฅ10. 6. Have used at least two standard immunosuppressants (including one biological agent). 7. SLEDAI-2K score โ‰ฅ6 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
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What it tests

  • AZD0120
  • Cyclophosphamide
  • Fludarabine
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Where

20 sites
Research Site
San Francisco, United States
Research Site
Stanford, United States
Research Site
Tampa, United States
Research Site
Atlanta, United States
Research Site
Chicago, United States
Research Site
Baltimore, United States
Research Site
Bethesda, United States
Research Site
Boston, United States

โ€ฆand 12 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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