A Study of AZD0120 in Autoimmune Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAstraZeneca
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AZD0120
Treatment groups
27 Participants
are divided into 2 treatment groupsLocations
18Australia
Research Site2010, Darlinghurst Australia
Research Site2298, Waratah Australia
Germany
Research Site20246, Hamburg Germany
Research Site55131, Mainz Germany
Sponsors and collaborators
AstraZeneca
Lead sponsor
Source ClinicalTrials.gov