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)
A Modular, Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120, a Dual-targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19 in Participants With Multiple Myeloma (DURGA-2)
1 other identifier
interventional
40
1 country
13
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 multiple-myeloma
Started Jul 2025
Shorter than P25 for phase_1 multiple-myeloma
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2025
CompletedFirst Posted
Study publicly available on registry
July 18, 2025
CompletedStudy Start
First participant enrolled
July 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 26, 2028
April 28, 2026
April 1, 2026
2.8 years
July 10, 2025
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adverse Events (AEs)
Incidence and severity of adverse events (AEs)
2 years
Serious Adverse Events (SAEs)
Incidence and severity of serious adverse events (SAEs)
2 years
Dose Limiting Toxicities (DLT)
Incidence of dose limiting toxicities events
28 days
Secondary Outcomes (17)
Pharmacokinetic - AUC0-28d
0-28 Days
Pharmacokinetic AUC0-3M
0 - 3 Months
Pharmacokinetic AUClast
2 years
Pharmacokinetic - Cmax
2 years
Pharmacokinetic - Tmax
2 years
- +12 more secondary outcomes
Study Arms (1)
AZD0120
EXPERIMENTALAZD0120 will be administrated in one infusion
Interventions
AZD0120 is a BCMA/CD19 dual CAR T cell product under investigation for early-line treatment in subjects with multiple myeloma
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (13)
Research Site
Phoenix, Arizona, 85054, United States
Research Site
Duarte, California, 91010, United States
Research Site
Denver, Colorado, 80218, United States
Research Site
Tampa, Florida, 33612, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Iowa City, Iowa, 52242, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
New York, New York, 10016, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Dallas, Texas, 75235, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Charlottesville, Virginia, 22903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2025
First Posted
July 18, 2025
Study Start
July 31, 2025
Primary Completion (Estimated)
May 26, 2028
Study Completion (Estimated)
May 26, 2028
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.