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
AstraZeneca
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).
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalAZD0120
CD19/BCMA Autologous CAR T-cell therapy product
Locations (18)
- Research SiteTucson, Arizona
- Research SiteStanford, California
- Research SiteChicago, Illinois
- Research SiteAnn Arbor, Michigan
- Research SiteSt Louis, Missouri
- Research SiteNew York, New York