RightFit
RecruitingPhase 1 / Phase 2

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests AZD0120, a CAR T-cell treatment that uses immune cells to target cells marked CD19 and BCMA. It looks at safety, side effects, and how well the treatment works in adults with systemic lupus erythematosus (SLE), or lupus, that has not responded to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 70 years old.
  • Give written consent and be willing and able to follow the study visit schedule and rules.
  • Have liver, kidney, lung, and heart function that meets study requirements.
  • Have lupus that meets the study’s diagnosis rules, including an ANA blood test result of at least 1:80 and a diagnosis score of at least 10.
  • Have used at least two standard medicines that reduce immune system activity, including one biologic medicine.
  • Have a lupus activity score (SLEDAI-2K) of at least 6 at screening.
  • Have major lupus effects on the body, such as joint or muscle swelling, rash, hair loss, sores inside the mouth or other moist areas, kidney problems, or swelling of blood vessels or the lining around the lungs or heart.
  • If you have lupus kidney disease, have class III, IV, or V disease shown by a kidney tissue test done within 6 months before consent or during screening.

Who can't join

  • Have had any CAR T-cell treatment before.
  • Have had treatment that targets CD19 or BCMA.
  • Have had a stem cell transplant using your own cells or a donor’s cells.
  • Have cancer that is getting worse or needs active treatment.
  • Have a primary immune deficiency, a condition that causes a weak immune system.
  • Have an active viral or bacterial infection.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (16)

CA

FL

GA

IL

MA

MD

MO

NC

NY

VA

WA