RecruitingPhase 1

A Study of AZD0120 in Autoimmune Diseases

A Phase 1b, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases

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 75 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 the safety of AZD0120, a CAR T-cell treatment that uses changed immune cells, and how well people can handle it. It is for adults with systemic sclerosis (a disease that causes tissue hardening), idiopathic inflammatory myopathies (diseases that cause muscle swelling), or hard-to-treat rheumatoid arthritis.

This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).

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

Eligibility

Who can join

  • You can sign a form agreeing to join after learning about the study.
  • Your body and organs work well enough to take part.
  • You can stop certain medicines for the required time before treatment.
  • The study doctor finds that the study is suitable for you.
  • You agree to use highly effective birth control, or meet other accepted requirements.

Who can't join

  • Your body mass index (BMI), a measure based on height and weight, is below 18 or above 35.
  • You have had CAR T-cell treatment, a bone marrow transplant, or an organ transplant, or are on an active transplant waiting list.
  • You cannot or will not stay within about 2 hours of the study site for 28 days after treatment.
  • You recently received an experimental drug, have certain serious allergies to study treatment ingredients, or cannot safely receive the required drugs fludarabine and cyclophosphamide.
  • You have certain heart or brain and spinal cord conditions, uncontrolled or symptom-causing high blood pressure, recent serious bleeding, or need oxygen at rest or a breathing machine. Nighttime oxygen for sleep apnea is allowed.
  • You have another autoimmune disease, certain inherited immune problems, or a history of cancer. Some exceptions apply. Certain active or recent infections, HIV, active hepatitis, or active syphilis also rule out joining.
  • Your vaccines are not up to date, or you recently received a live vaccine. Major surgery or surgery planned during the study may also rule out joining.
  • You are pregnant or breastfeeding, or plan to become pregnant or father a child during the study or within 1 year after treatment, whichever ends later.

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

Official eligibility criteria

Inclusion Criteria: * Capable of giving signed informed consent. * Adequate physiological function and reserve at screening. * Able to comply with recommended medication washout period. * Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator. * Willingness to remain on/start appropriate, highly effective methods of birth control or other acceptable criteria. Exclusion Criteria: * BMI at screening \< 18 or \> 35kg/m2. * Any prior CAR T exposure. * Unable or unwilling to remain within proximity (\~2 hours travel time) of the administering investigational site for the first 28 days post study drug administration. * Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list. * Received any investigational drug within ≥ 5 half-lives or 4 weeks, whichever is longer, prior to screening. * Has certain heart conditions that could make it unsafe or unsuitable to take part in the study. * Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation. * Uncontrolled hypertension (\> 160/100 mmHg) or symptomatic hypertension. * Any central nervous system disease that may impact participants safety in the investigator's opinion. * Other concurrent autoimmune or autoinflammatory disease. Certain autoimmune/autoinflammatory diseases may be included after discussion with the medical monitor. * Evidence of clinically significant bleeding or active bleeding conditions within 90 days before screening * History of malignancy or ongoing treatment for prior malignancy. Certain malignancies may be excepted. * Known genetic inborn error of immunity and/or primary immunodeficiency. * Active viral, bacterial, or fungal infection, or any ongoing infection that requires systemic antimicrobial therapy in the 4 weeks prior to screening. * Seropositive for HIV. * Active viral hepatitis are excluded. * Active syphilis, positive for Treponema pallidum antibody. * Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis or lymphodepletion. * Not up-to-date on vaccinations per local/national health authority or institutional guidelines for immune-compromised individuals. * Known life threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including dimethyl sulfoxide. * Contraindications or hypersensitivity to fludarabine and cyclophosphamide. * Major surgery, or has surgery planned during the study. * Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment (whichever is later). * Plans to father a child while enrolled in this study or within 1 year after receiving study treatment (whichever is later). * Any issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to provide informed consent or any condition in the opinion of the investigator, participation would not be in the best interest of the participant. Other protocol-defined eligibility criteria may apply.

Study sites (8)

AZ

CA

IL

MI

MO

NC

NY

WA