NCT06897930 · AstraZeneca
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
What this study is about
This is a Phase 1b/2, single-treatment group$1, where both patients and doctors know the treatment given, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and effectiveness in adult participants with refractory Systemic Lupus Erythematosus.
View original scientific description
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.
Interventions
BIOLOGICAL
AZD0120
Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy..
DRUG
Cyclophosphamide
Lymphodepletion - specified dose prior to receiving AZD0120
DRUG
Fludarabine
Lymphodepletion - specified dose prior to receiving AZD0120
Primary outcome measures
PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE)
Time frame: 2 years
The incidence and severity of adverse events (AEs)
PHASE 1B: Recommended Phase 2 Dose (RP2D) of AZD0120 in for Phase 2
Time frame: 2 years
To determine the recommended phase 2 dose (RP2D) of AZD0120
PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE
Time frame: 2 years
Proportion of participants achieving SRI-4 response
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 accord
Where
- San Francisco, California
- Stanford, California
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Bethesda, Maryland
- Boston, Massachusetts
- St Louis, Missouri
- New York, New York
- Syracuse, New York
- Chapel Hill, North Carolina
- Charlotte, North Carolina
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations