Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
AZD0120 will be administrated in one infusion
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AZD0120
AZD0120 will be administrated in one infusion
  • Biological: AZD0120
    AZD0120 is a BCMA/CD19 dual CAR T cell product under investigation for early-line treatment in subjects with multiple myeloma

Recruiting Locations

Research Site
Duarte, California 91010

Research Site
Denver, Colorado 80218

Research Site
Tampa, Florida 33612

Research Site
Atlanta, Georgia 30322

Research Site
Iowa City, Iowa 52242

Research Site
St Louis, Missouri 63110

Research Site
New York, New York 10016

Research Site
Nashville, Tennessee 37203

Research Site
Houston, Texas 77030

Research Site
Charlottesville, Virginia 22903

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

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 ± maintenance.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.