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Tests treatment safety and results for Lupus Erythematosus, Systemic
Official title A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
ClinicalTrials.gov ID: NCT06897930
What this study is testing
What is AZD0120?
AZD0120 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus erythematosus, systemic.
Also referred to as GC012F.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- INCLUSION:
- Males or females aged 18 through 70 years inclusive at the time of consent.
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Must be able and willing to adhere to the study visit schedule and other protocol requirements
- Adequate hepatic, renal, pulmonary, and cardiac function
See the full eligibility criteria
- INCLUSION:
- Males or females aged 18 through 70 years inclusive at the time of consent.
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Must be able and willing to adhere to the study visit schedule and other protocol requirements
- Adequate hepatic, renal, pulmonary, and cardiac function
- 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.
- Have used at least two standard immunosuppressants (including one biological agent).
- SLEDAI-2K score ≥6 at screening.
- Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.
- 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...
- Have received prior treatment with CAR T therapy directed at any target.
- Have received any therapy that is targeted to CD19 and/or BCMA
- Received allogenic stem cell transplant or autologous stem cell transplant.
- An active malignancy that is progressing or requires active treatment.
- Primary immunodeficiency
- Active viral or bacterial infection
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Stanford, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, 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
- Darlinghurst, Australia
- Melbourne, Australia
- Toronto, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Stanford, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Bethesda, Maryland, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.