About this trial
This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females ≥18 years of age at the time of consent
Participant must have documented diagnosis of MM per IMWG diagnostic criteria
ECOG performance status of 0 or 1.
Adequate organ and bone marrow function.
Disqualifiers
Have received prior treatment with CAR T therapy directed at any target
Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
Active or history of plasma cell leukemia at the time of screening
Seropositive for human immunodeficiency virus (HIV)
Trial design
Single group
Treatments tested in this trial
AZD0120
Biological/VaccineAZD0120 is a BCMA/CD19 dual CAR T cell product under investigation for early-line treatment in subjects with multiple myeloma
Treatment groups
Trial outcomes
Primary outcomes
Adverse Events (AEs)
Incidence and severity of adverse events (AEs)
Serious Adverse Events (SAEs)
Incidence and severity of serious adverse events (SAEs)
Dose Limiting Toxicities (DLT)
Incidence of dose limiting toxicities events
Secondary outcomes
Pharmacokinetic - AUC0-28d
Area under the concentration time-curve of AZD0120 level
Pharmacokinetic AUC0-3M
Area under the concentration time-curve of AZD0120 level
Pharmacokinetic AUClast
Area under the concentration time-curve of AZD0120 level
Pharmacokinetic - Cmax
Maximum AZD0120 level
Sponsors and contacts
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