Systemic Sclerosis study: AZD0120 vs SOC
Official title A Study of AZD0120 in Autoimmune Diseases
ClinicalTrials.gov ID: NCT07295847
What this study is testing
What is AZD0120?
an investigational autologous CAR T‑cell therapy being studied as a potential treatment for systemic sclerosis is designed to target CD19 and BCMA proteins on immune cells
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
- The study aims to learn whether AZD0120 is safe and tolerable for people with these autoimmune conditions.
- Who it's for
- Adults who have systemic sclerosis, idiopathic inflammatory myopathies, or difficult‑to‑treat rheumatoid arthritis.
- What's involved
- Participants will receive an infusion of AZD0120, a lab‑made immune cell (CAR‑T) treatment, and undergo safety monitoring, lab tests, and clinic visits.
- Time commitment
- The trial follows participants for several months with multiple clinic visits to check safety.
- 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 75
You may be able to join if
- 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.
You likely can't join if
- Any prior CAR T exposure.
- Unable or unwilling to remain within proximity (2 hours travel time) of the administering investigational site post discharge for the first 28 days...
- 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 cardiac 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.
See the full eligibility 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.
- Particpant musy be 18-years-old to ≤ 75-years-old inclusive at the time of signing the informed consent
- Others as described in Clinical Study Protocol
- Any prior CAR T exposure.
- Unable or unwilling to remain within proximity (2 hours travel time) of the administering investigational site post discharge for the first 28 days post AZD0120 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 cardiac 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 or HTLV.
- 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 within 8 weeks prior to apheresis 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...
- Other protocol-defined eligibility criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Darlinghurst, Australia
- Edinburgh, United Kingdom
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, but 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ann Arbor, Michigan, United States; New York, New York, United States; Chapel Hill, North Carolina, United States; Darlinghurst, Australia; Edinburgh, United Kingdom. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.