AstraZeneca
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.
Inclusion Criteria: * Participant must be 18 years or older at the time of signing the informed consent form. * Participants must have documented diagnosis of MM according to the IMWG diagnostic criteria. * Participant must have one or more of the following measurable disease criteria: * Serum M-protein level ≥ 1.0 g/dL. * Urine M-protein ≥ 200 mg/24 h. * Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio. * ECOG performance score of 0 to 1. * Participant must have screening bone marrow aspirate and/or archi…
Allogeneic Chimeric Antigen Receptor T cell (CAR-T) Therapy Targeting B Cell Maturation Antigen (BCMA)
Anti-CD38 monoclonal antibody
Recombinant human IL-2