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A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
NCT06897930 · AstraZeneca
In plain English
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Official title
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)
About this study
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 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
Study design
Enrollment target: 150 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-21
Estimated completion: 2029-05-01
Last updated: 2026-04-08
Interventions
Biological: AZD0120Drug: CyclophosphamideDrug: Fludarabine
Primary outcomes
- • PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE) (2 years)
- • PHASE 1B: Recommended Phase 2 Dose (RP2D) of AZD0120 in for Phase 2 (2 years)
- • PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE (2 years)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (16)
Research SiteNot Yet Recruiting
San Francisco, California, United States
Research SiteNot Yet Recruiting
Stanford, California, United States
Research SiteSuspended
Tampa, Florida, United States
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Atlanta, Georgia, United States
Research SiteWithdrawn
Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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St Louis, Missouri, United States
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New York, New York, United States
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Syracuse, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Darlinghurst, Australia
Research SiteNot Yet Recruiting
Melbourne, Australia