AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
DURGA-1
A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)
2 other identifiers
interventional
182
1 country
36
Brief Summary
This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2023
Longer than P75 for phase_1
36 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
April 18, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedStudy Start
First participant enrolled
July 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 14, 2028
May 6, 2026
May 1, 2026
4.1 years
April 18, 2023
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Phase 1b: Adverse Events (AEs)
The incidence and severity of AEs.
Through study completion, a minimum of 2 years.
Phase 1b: Dose-Limiting Toxicities (DLTs)
The DLT evaluation period is defined as the first 28 days after infusion.
28 days
Phase 2: Objective Response Rate (ORR)
Defined as the proportion of participants who achieved partial response (PR) or better by the International Myeloma Working Group (IMWG) response criteria.
Through study completion, a minimum of 2 years.
Secondary Outcomes (17)
Phase 1b and 2: Complete response rate (CRR)
Through study completion, a minimum of 2 years.
Phase 1b and 2: Time to response (TTR)
Through study completion, a minimum of 2 years.
Phase 1b: Objective Response Rate (ORR)
Through study completion, a minimum of 2 years.
Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate
Through study completion, a minimum of 2 years.
Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate at 12 months
12 months
- +12 more secondary outcomes
Study Arms (1)
AZD0120
EXPERIMENTALAZD0120 will be administered by infusion
Interventions
AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.
Eligibility Criteria
You may qualify if:
- ≥18 years of age at the time of consent.
- ECOG performance status of 0 or 1.
- Documented diagnosis of MM per IMWG diagnostic criteria.
- Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
- Have documented evidence of progressive disease per IMWG criteria.
- Participant must have measurable disease at screening.
- Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening.
You may not qualify if:
- Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy.
- Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. Some exceptions may apply.
- Participant has significant cardiac, neurological, or psychiatric conditions.
- Any other significant medical conditions such as:
- Serious active or uncontrolled infection
- Active autoimmune disease or a history of autoimmune disease within 2 years
- Active plasma cell leukemia at the time of screening
- Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF).
- Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (36)
Research Site
Birmingham, Alabama, 35233, United States
Research Site
Phoenix, Arizona, 85054, United States
Research Site
La Jolla, California, 92037, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
San Francisco, California, 94143, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Denver, Colorado, 80218, United States
Research Site
Jacksonville, Florida, 32224, United States
Research Site
Miami, Florida, 33136, United States
Research Site
Tampa, Florida, 33612, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Chicago, Illinois, 60637, United States
Research Site
Iowa City, Iowa, 52242, United States
Research Site
Boston, Massachusetts, 02114, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
Ann Arbor, Michigan, 48109, United States
Research Site
Detroit, Michigan, 48202, United States
Research Site
Minneapolis, Minnesota, 55455, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
Omaha, Nebraska, 68198, United States
Research Site
Hackensack, New Jersey, 07601, United States
Research Site
Buffalo, New York, 14203, United States
Research Site
New York, New York, 10065, United States
Research Site
Stony Brook, New York, 11794, United States
Research Site
Charlotte, North Carolina, 28204, United States
Research Site
Durham, North Carolina, 27705, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Nashville, Tennessee, 37232, United States
Research Site
Austin, Texas, 78704, United States
Research Site
Dallas, Texas, 75390, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Salt Lake City, Utah, 84112, United States
Research Site
Charlottesville, Virginia, 22908, United States
Research Site
Edmonds, Washington, 98026, United States
Research Site
Seattle, Washington, 98109, United States
Research Site
Milwaukee, Wisconsin, 53226, 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
April 18, 2023
First Posted
May 9, 2023
Study Start
July 20, 2023
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
November 14, 2028
Last Updated
May 6, 2026
Record last verified: 2026-05
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.