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Engineered immune cells take on Hard-to-Treat myeloma

NCT ID NCT07681596

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 101 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    12 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Research Site

    RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    NOT_YET_RECRUITING

    Denver, Colorado, 80218, United States

  • Research Site

    NOT_YET_RECRUITING

    Tampa, Florida, 33612, United States

  • Research Site

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Research Site

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

  • Research Site

    NOT_YET_RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Research Site

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Research Site

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Research Site

    NOT_YET_RECRUITING

    Camperdown, 2050, Australia

  • Research Site

    RECRUITING

    East Melbourne, 3002, Australia

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