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NCT07295847 | RECRUITING | Systemic Sclerosis

A Study of AZD0120 in Autoimmune Diseases
Sponsor:

AstraZeneca

Brief Summary:

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).

Condition or disease

Systemic Sclerosis

Idiopathic Inflammatory Myopathies

Rheumatoid Arthritis

Intervention/treatment

AZD0120

Phase

PHASE1

Detailed Description:

This is a Phase 1b, open-label, multi-center, multi-cohort clinical study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, to evaluate the safety in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA) for determination of the recommended phase 2 dose for each disease cohort. Approximately 9-12 participants will be evaluated per disease cohort.

Study Type : INTERVENTIONAL
Estimated Enrollment : 27 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2026-01-09
Estimated Primary Completion Date : 2028-02-22
Estimated Study Completion Date : 2028-02-22

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study of AZD0120 in Autoimmune Diseases

Location Details

NCT07295847

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Arizona

Research Site

Tucson, arizona, United States, 85719

NOT YET RECRUITING

United States, California

Research Site

Stanford, California, United States, 94305-5847

NOT YET RECRUITING

United States, Illinois

Research Site

Chicago, Illinois, United States, 60637

NOT YET RECRUITING

United States, road cancer

Research Site

Ann Arbor, road cancer, United States, 48109

NOT YET RECRUITING

United States, Missouri

Research Site

St Louis, Missouri, United States, 63110

RECRUITING

United States, New York

Research Site

New York, New York, United States, 10032

NOT YET RECRUITING

United States, North Carolina

Research Site

Chapel Hill, North Carolina, United States, 27514

NOT YET RECRUITING

United States, Washington

Research Site

Seattle, Washington, United States, 98104

RECRUITING

Australia,

Research Site

Darlinghurst, Australia, 2010

NOT YET RECRUITING

Australia,

Research Site

Waratah, Australia, 2298

NOT YET RECRUITING

Germany,

Research Site

Hamburg, Germany, 20246

NOT YET RECRUITING

Germany,

Research Site

Mainz on the Rhine, Germany, 55131

NOT YET RECRUITING

Germany,

Research Site

Würzburg, Germany, 97080

NOT YET RECRUITING

Spain,

Research Site

Barcelona, Spain, 8035

NOT YET RECRUITING

Spain,

Research Site

Madrid, Spain, 28041

NOT YET RECRUITING

Spain,

Research Site

Madrid, Spain, 28046

NOT YET RECRUITING

United Kingdom,

Research Site

Edinburgh, United Kingdom, EH4 2XU

NOT YET RECRUITING

United Kingdom,

Research Site

London, United Kingdom, SE5 9RS