A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma

Starting soon · Phase 1/Phase 2

Conditions studied: Relapsed or Refractory Multiple Myeloma

In brief

The purpose of this study is to assess the safety, tolerability, preliminary efficacy, cellular kinetics, and other exploratory endpoints of AZD4045 as a monotherapy and in association with daratumumab and aldesleukin for the treatment of adult participants with RRMM.

Key facts

Study ID

NCT07681596

Run by

AstraZeneca

People needed

101

Starts

2026-07-09

Expected to finish

2029-10-30

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be 18 years or older at the time of signing the informed consent form.
• Participants must have documented diagnosis of MM according to the IMWG diagnostic criteria.
• Participant must have one or more of the following measurable disease criteria:
• Serum M-protein level ≥ 1.0 g/dL.
• Urine M-protein ≥ 200 mg/24 h.
• Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio.
• ECOG performance score of 0 to 1.
• Participant must have screening bone marrow aspirate and/or archival sample adequate for clonal sequence calibration for MRD. An archival sample obtained from any time prior is acceptable.
• Participant must have adequate organ and bone marrow function.
• Participant must have received at least 3 prior classes of therapy, including a PI, an IMiD, and an anti-CD38 antibody
• Participant must have documented evidence of PD by IMWG 2016 criteria based on Investigator's determination during or after the most recent line of therapy

You may not qualify if…

• Participant has a history of any grade IEC-HS and/or history of Grade ≥ 3 CRS and/or Grade ≥ 2 neurotoxicities during prior CAR-T cell therapy or T cell engaging therapy.
• Participant has ongoing toxicity from previous anti-cancer therapy that did not resolve to baseline levels or to Grade ≤ 1 with the exception of alopecia or peripheral neuropathy.
• Participant has a known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
• Participant has systemic immunoglobulin light chain amyloidosis, active plasma cell leukaemia (presence of ≥ 5% of circulating plasma cells on a conventional peripheral blood smear) at time of screening, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.
• Participant has a history of haematologic malignancies, other than MM, regardless of remission status.
• Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years.
• Participant has significant neurological or psychiatric condition (active or history of).
• Participant is positive for any of the following:
• HIV (with exceptions)
• Chronic or active hepatitis B
• Active hepatitis C
• Participant has clinically significant cardiovascular disease, including but not limited to:
• Myocardial infarction within 6 months prior to eligibility confirmation, or an unstable or uncontrolled disease/condition related to or affecting cardiac function.
• Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities.
• Congestive heart failure Class III or IV.
• Impaired cardiac function (LVEF < 45%).
• Participant has any other significant medical condition which, in the opinion of the Investigator, places the participant at an unacceptable risk for treatment-related complications, could interfere with the successful or safe delivery of therapy, or could interfere with evaluation of study intervention or interpretation of participant safety or study results. These include but are not limited to:
• Serious active or uncontrolled infection.
• Requirement of supplemental oxygen to maintain oxygen saturation.
• Active autoimmune disease or a history of autoimmune disease within 2 years.
• Inflammatory bowel disease requiring treatment within the past 5 years or other clinically significant gastrointestinal condition.
• Participant received live, attenuated vaccine within 28 days prior to eligibility confirmation
• Participant has undergone major surgery within 28 days prior to eligibility confirmation
• Concurrent enrolment in another clinical study (unless the study is observational, or the participant is in the follow-up period of an interventional study).
• Participant has a known life-threatening allergy, hypersensitivity, intolerance, or a contraindication to any study intervention or their excipients.

Where it is running

• Research Site — Duarte, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Hackensack, New Jersey, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — Milwaukee, Wisconsin, United States
• Research Site — Camperdown, Australia
• Research Site — East Melbourne, Australia

Full record on ClinicalTrials.gov

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