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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
CD19/BCMA Autologous CAR T-cell therapy product
Research Site
Tucson, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Stanford, California, United States
Number of participants and severity of dose limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)
Incidence and severity of DLTs and TEAEs to evaluate the safety of AZD0120 and to confirm the recommended Phase 2 dose (RP2D) in each indication SSc, IIM, or RA
Time frame: 1 year
Cellular Kinetics - Cmax
The maximum concentration of CAR T cells achieved in the body.
Time frame: 1 year
Cellular Kinetics - Tmax
The time point at which the Cmax is reached
Time frame: 1 year
Cellular Kinetics - AUC
The area under the concentration-time curve, which represents the total drug exposure over a specific period.
Time frame: 1 year
Cellular Kinetics - t½λz
The terminal elimination half-life.
Time frame: 1 year
Cellular Kinetics - Clast
The last observed quantifiable concentration of CAR T-cells.
Time frame: 1 year
Cellular Kinetics - Tlast
The time to last quantifiable concentration.
Time frame: 1 year
Cellular Kinetics - AUClast
The area under the concentration-time curve to the last measurable concentration.
Time frame: 1 year
AstraZeneca Clinical Study Information Center
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Research Site
Chicago, Illinois, United States
NOT_YET_RECRUITINGResearch Site
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGResearch Site
St Louis, Missouri, United States
NOT_YET_RECRUITINGResearch Site
New York, New York, United States
RECRUITINGResearch Site
Chapel Hill, North Carolina, United States
NOT_YET_RECRUITINGResearch Site
Seattle, Washington, United States
NOT_YET_RECRUITINGResearch Site
Darlinghurst, Australia
RECRUITINGResearch Site
Waratah, Australia
NOT_YET_RECRUITING...and 8 more locations
Anti-drug antibodies (ADA) developed against AZD0120 from baseline
Humoral immunogenicity assessment of AZD0120 in participants with SSc, IIM, or RA.
Time frame: 1 year
Proportion of participants with detectable replication competent lentivirus (RCL) at pre-specified post infusion timepoints.
Incidence of vector-derived RCL in participant receiving AZD0120.
Time frame: 1 year
Change from baseline in the Disease Activity Score (DAS) 28-C-reactive protein (CRP). The DAS28-CRP is a measure from 0-10 with higher scores indicating greater disease activity.
Disease activity measures in RA participants.
Time frame: 1 year
Change from baseline in modified Rodnan Skin Score (mRSS). The mRSS is a measure of skin thickness with a range of 0-51 with higher scores indicating more severe disease.
Disease activity measures in SSc participants.
Time frame: 1 year
Change from baseline in the total improvement score (TIS). The TIS ranges from 0-100 with higher scores indicating greater improvement.
Disease activity measures in IIM participants.
Time frame: 1 year