NCT07295847 A Study of AZD0120 in Autoimmune Diseases
| NCT ID | NCT07295847 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | AstraZeneca |
| Condition | Systemic Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2026-01-09 |
| Primary Completion | 2028-02-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2026-01-09 with a primary completion date of 2028-02-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07295847 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Systemic Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07295847 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07295847 currently recruiting?
Yes, NCT07295847 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07295847 trial being conducted?
This trial is being conducted at Tucson, United States, Stanford, United States, Chicago, United States, Ann Arbor, United States and 11 additional locations.
Who is sponsoring the NCT07295847 clinical trial?
NCT07295847 is sponsored by AstraZeneca. The trial plans to enroll 27 participants.