Engineered immune cells take on Hard-to-Treat myeloma
NCT ID NCT07681596
First seen Jul 02, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This study tests a new treatment called AZD4045, which uses specially engineered immune cells (CAR-T cells) to target and kill multiple myeloma cells. The therapy is given alone or combined with other drugs (daratumumab and aldesleukin) in adults whose myeloma has returned or stopped responding to prior treatments. The goal is to see if it is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD4045 (allogeneic CAR-T cells targeting BCMA), daratumumab, aldesleukin
- What this could lead to
- If successful, this could offer a new treatment option for people with multiple myeloma that has stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial, so the treatment may not work or could cause serious side effects. The approach is complex and still experimental.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 101 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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: 1. HIV (with exceptions) 2. Chronic or active hepatitis B 3. Active hepatitis C * Participant has clinically significant cardiovascular disease, including but not limited to: 1. Myocardial infarction within 6 months prior to eligibility confirmation, or an unstable or uncontrolled disease/condition related to or affecting cardiac function. 2. Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities. 3. Congestive heart failure Class III or IV. 4. 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: 1. Serious active or uncontrolled infection. 2. Requirement of supplemental oxygen to maintain oxygen saturation. 3. Active autoimmune disease or a history of autoimmune disease within 2 years. 4. 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. * Participant received any prior CAR-T or CAR-NK therapy directed at any target within 6 months prior to eligibility confirmation. * Participant received any prior TCE therapy directed at any target within 6 months prior to eligibility confirmation. * Participant received any prior BCMA-targeted treatment within 6 months prior to eligibility confirmation. * Participant with a history of refractoriness to the most recent BCMA-targeted treatment received as defined as PD on or within 60 days of last dose or non-responsiveness (ie, did not achieve at least minimal response) on therapy. * Participant received prior allogeneic stem cell transplant at any time. * Participant received autologous stem cell transplant within 3 months prior to eligibility confirmation. * Participant received radiation therapy for treatment of plasmacytoma within 14 days before eligibility confirmation. * Participant received prior anti-tumour therapy as follows prior to the first dose of lymphodepletion: a) Within 7 days: * Immunomodulatory or cereblon E3 ligase modulatory drugs. b) Within 14 days: * PI therapy. * Monoclonal antibody treatment for MM. * Cytotoxic therapy. * Other systemic anti-myeloma therapy. * Radiation. c) Within 14 days or at least 5 half-lives, whichever is longer: * Targeted therapy, epigenetic therapy, investigational drug or used an invasive investigational medical device.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
RECRUITINGDuarte, California, 91010, United States
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Research Site
NOT_YET_RECRUITINGDenver, Colorado, 80218, United States
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Research Site
NOT_YET_RECRUITINGTampa, Florida, 33612, United States
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Research Site
NOT_YET_RECRUITINGAtlanta, Georgia, 30322, United States
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Research Site
NOT_YET_RECRUITINGSt Louis, Missouri, 63110, United States
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Research Site
NOT_YET_RECRUITINGHackensack, New Jersey, 07601, United States
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Research Site
NOT_YET_RECRUITINGCleveland, Ohio, 44195, United States
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Research Site
NOT_YET_RECRUITINGNashville, Tennessee, 37203, United States
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Research Site
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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Research Site
NOT_YET_RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Research Site
NOT_YET_RECRUITINGCamperdown, 2050, Australia
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Research Site
RECRUITINGEast Melbourne, 3002, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding selinexor to standard therapy extend remission in Hard-to-Treat myeloma?
- Can a new drug combo outsmart Hard-to-Treat myeloma?
- Home infusion for myeloma drug passes early safety check
- New hope for multiple myeloma: phase 3 trial launches
- New CAR T-Cell therapy targets Hard-to-Treat myeloma
- New 'Off-the-Shelf' CAR-T therapy takes on Hard-to-Treat myeloma