The purpose of this study is to assess the safety, tolerability, preliminary efficacy, cellular kinetics, and other exploratory endpoints of AZD4045 as a monotherapy and in association with daratumumab and aldesleukin for the treatment of adult participants with RRMM.
This modular study aims to evaluate the safety, tolerability, preliminary efficacy, and cellular kinetics of AZD4045 in participants with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose of AZD4045. Module 1 consists of AZD4045 as a monotherapy and in association with daratumumab and aldesleukin.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Allogeneic Chimeric Antigen Receptor T cell (CAR-T) Therapy Targeting B Cell Maturation Antigen (BCMA)
Anti-CD38 monoclonal antibody
Recombinant human IL-2
Research Site
Duarte, California, United States
RECRUITINGResearch Site
Denver, Colorado, United States
NOT_YET_RECRUITINGAdverse events (AEs) and serious AEs (SAEs)
Incidence and severity of adverse events (AEs) and serious AEs (SAEs)
Time frame: Through study completion, an average of 2 years
Dose-limiting toxicities (DLT)
Incidence and severity of dose-limiting toxicity (DLT) events
Time frame: 28 days
Efficacy - Objective Response Rate (ORR)
Defined as proportion of participants who achieve an overall response of PR or better according to the IMWG 2016 criteria
Time frame: Through study completion, an average of 2 years
Efficacy - Complete Response Rate (CRR)
Defined as proportion of participants who achieve a CR/sCR response according to the to the IMWG 2016 criteria
Time frame: Through study completion, an average of 2 years
Efficacy - Duration of Response (DOR)
Defined as the time from first documented confirmed response until date of documented PD per IMWG 2016 criteria or death due to any cause, whichever occurs first
Time frame: Through study completion, an average of 2 years
Efficacy - Time to Response (TTR)
Defined as the time from infusion until the date of first documented objective response, as assessed per IMWG 2016 criteria
Time frame: Through study completion, an average of 2 years
Cellular kinetics - Quantification of CAR transgene levels
Determination of transgene level
Time frame: Through study completion, an average of 2 years
AstraZeneca Clinical Study Information Center
CONTACT
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Research Site
Tampa, Florida, United States
NOT_YET_RECRUITINGResearch Site
Atlanta, Georgia, United States
NOT_YET_RECRUITINGResearch Site
St Louis, Missouri, United States
NOT_YET_RECRUITINGResearch Site
Hackensack, New Jersey, United States
NOT_YET_RECRUITINGResearch Site
Cleveland, Ohio, United States
NOT_YET_RECRUITINGResearch Site
Nashville, Tennessee, United States
NOT_YET_RECRUITINGResearch Site
Houston, Texas, United States
NOT_YET_RECRUITINGResearch Site
Milwaukee, Wisconsin, United States
NOT_YET_RECRUITING...and 2 more locations
Cellular kinetics - Tmax
Time to reach maximum AZD4045 level
Time frame: Through study completion, an average of 2 years
Cellular kinetics - Cmax
Maximum AZD4045 level
Time frame: Through study completion, an average of 2 years
Cellular kinetics - AUC0-28d
Area under the concentration time-curve of AZD4045 level
Time frame: 0 - 28 days
Cellular kinetics - Tlast
Time to last quantifiable concentration of AZD4045 level
Time frame: Through study completion, an average of 2 years
Cellular kinetics - Clast
Observed concentration of AZD4045 at last quantifiable concentration
Time frame: Through study completion, an average of 2 years
Cellular kinetics - AUClast
Area under the concentration time-curve of AZD4045 level
Time frame: Through study completion, an average of 2 years