A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120 in Participants With Multiple Myeloma (DURGA-2)
Recruiting
Phase 1Interventional Study
Multiple Myeloma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
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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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Age:
* Males and females ≥18 years of age at the time of consent
Type of Participant and Disease Characteristics:
* Participant must have documented diagnosis of MM per IMWG diagnostic criteria
* ECOG performance status of 0 or 1.
* Adequate organ and bone marrow function.
F…
Inclusion Criteria:
Age:
* Males and females ≥18 years of age at the time of consent
Type of Participant and Disease Characteristics:
* Participant must have documented diagnosis of MM per IMWG diagnostic criteria
* ECOG performance status of 0 or 1.
* Adequate organ and bone marrow function.
For NDMM participants:
* Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable)
* For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and a maximum of 6 cycles of induction therapy completed prior to screening
* Classified as high-risk MM
For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:
* Have received and failed 1 or 2 lines of anti-myeloma therapy
* Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy
* Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen
General Exclusion Criteria:
* 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)
* Active Hepatitis B infection
* Active Hepatitis C infection
* Serious underlying medical condition
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