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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
Trial Status: active
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).
Inclusion 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.
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 maximum of 6 cycles and
minimum of 4 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
Additional locations may be listed on ClinicalTrials.gov for NCT07073547.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
This modular study aims to evaluate the safety, tolerability, cellular kinetics,
pharmacodynamic effect, immunogenicity, and preliminary efficacy of AZD0120 in subjects
with newly diagnosed or early relapsed or primary refractory multiple myeloma. Module 1
consists of early line MM (including newly diagnosed MM and early relapsed or primary
refractory MM) with AZD0120 (for newly diagnosed multiple myeloma (NDMM), the
intervention is with AZD0120 ± maintenance). Module 2 consists of NDMM with AZD0120 ±