Phase 1 / Phase 2: testing AZD0120 for Systemic Sclerosis

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are AZD0120, or SOC. The registry lists allocation as na. This trial is a Phase 1b/2, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to measure the whether it is safe and how hard side effects are to live with in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).

They plan to enroll about 27 people at 25 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

A Phase 1b/2, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases

Interventions: AZD0120, SOC

Primary outcome (registry wording): Number of participants and severity of dose limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)

Who it is for (from inclusion criteria)

• Ages 18 Years to 75 Years
• 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
• Others as described in Clinical Study Protocol