Phase
Condition
Red Blood Cell Disorders
Lymphoproliferative Disorders
Multiple Myeloma
Treatment
AZD0120
GC012F (AZD0120)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 prioranti- myeloma therapy (no more than 2 cycles of induction therapy before enrollmentare acceptable)
For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and amaximum 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 partof their previous therapy
Have documented evidence of progressive disease based on investigator'sdetermination 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 ofanti-myeloma therapy, or have confirmed progressive disease within 6 months prior toscreening and who are subsequently determined to be refractory or non-responsive totheir most recent anti-myeloma treatment regimen
Exclusion
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 orexhibits 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
Study Design
Study Description
Connect with a study center
Research Site
Phoenix, Arizona 85054
United StatesSite Not Available
Research Site
Duarte, California 91010
United StatesActive - Recruiting
Research Site
Denver, Colorado 80218
United StatesActive - Recruiting
Research Site
Tampa, Florida 33612
United StatesSite Not Available
Research Site
Atlanta, Georgia 30322
United StatesActive - Recruiting
Research Site
Iowa City, Iowa 52242
United StatesActive - Recruiting
Research Site
Rochester, Minnesota 55905
United StatesSite Not Available
Research Site
St Louis, Missouri 63110
United StatesActive - Recruiting
Research Site
New York, New York 10016
United StatesActive - Recruiting
Research Site
Nashville, Tennessee 37203
United StatesActive - Recruiting
Research Site
Dallas, Texas 75235
United StatesSite Not Available
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
Charlottesville, Virginia 22903
United StatesActive - Recruiting

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