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One-shot CAR-T therapy takes on stem cell transplant for multiple myeloma

NCT ID NCT07735637

Cure Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a single infusion of AZD0120, a CAR-T cell therapy that targets two proteins on myeloma cells, can outperform the standard approach of high-dose chemotherapy followed by a stem cell transplant. The study enrolls adults newly diagnosed with multiple myeloma who have already completed initial treatment. Researchers will compare how long the cancer stays under control and whether the CAR-T approach leads to deeper remissions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental dual-targeting CAR-T cell therapy called AZD0120, which targets two proteins (BCMA and CD19) on myeloma cells
What this could lead to
If successful, this could offer a less intensive, one-time treatment alternative to stem cell transplant for newly diagnosed multiple myeloma, potentially improving long-term remission rates.
What could go wrong
This is an early-phase trial comparing a new therapy to a standard procedure. CAR-T therapy can cause serious side effects like cytokine release syndrome and neurological issues, and it is not yet proven to be better than stem cell transplant.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 750 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2039

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 to 130 years

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: * ≥18 years of age. * Documented diagnosis of NDMM according to IMWG diagnostic criteria. * Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio) * Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd * Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation. * ECOG performance status score of 0 or 1. * Eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT. * Adequate organ and bone marrow function. Exclusion Criteria: * Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM. * Primary amyloidosis, active plasma cell leukaemia (at diagnosis and/or at time of screening), Waldenstrom macroglobulinemia or POEMS syndrome. * Significant neurological or psychiatric condition * Significant medical condition that places the participant at an unacceptable risk for treatment-related complications * Participants who required the introduction of an additional agent therapy due to inadequate response. * Prior T-cell engager therapy directed at any target. * Prior CAR-T and/or CAR-NK cell therapy directed at any target for any indications * Prior any therapy that is targeted to BCMA and CD19.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Newly diagnosed multiple myeloma (NDMM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    65 sites in 15 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

    Tampa, Florida, 33612, United States

  • Research Site

    Atlanta, Georgia, 30322, United States

  • Research Site

    Atlanta, Georgia, 30342, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Detroit, Michigan, 48201, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    Cleveland, Ohio, 44195, United States

  • Research Site

    San Antonio, Texas, 78229, United States

  • Research Site

    Seattle, Washington, 98104, United States

  • Research Site

    Milwaukee, Wisconsin, 53226, United States

  • Research Site

    Brisbane, 4102, Australia

  • Research Site

    Camperdown, 2050, Australia

  • Research Site

    Darlinghurst, 2010, Australia

  • Research Site

    Fitzroy, VIC3065, Australia

  • Research Site

    Melbourne, 3004, Australia

  • Research Site

    Nedlands, 6009, Australia

  • Research Site

    Salvador, 41253-190, Brazil

  • Research Site

    São Paulo, 01509-900, Brazil

  • Research Site

    São Paulo, 05652-900, Brazil

  • Research Site

    Calgary, Alberta, T2N 5G2, Canada

  • Research Site

    Aarhus, 8200, Denmark

  • Research Site

    København Ø, 2100, Denmark

  • Research Site

    Odense, 5464, Denmark

  • Research Site

    Lille, 59037, France

  • Research Site

    Nantes, 44093, France

  • Research Site

    Paris, 75012, France

  • Research Site

    Paris, 75475, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Berlin, 10117, Germany

  • Research Site

    Dresden, 01307, Germany

  • Research Site

    Essen, 45122, Germany

  • Research Site

    Freiburg im Breisgau, 79106, Germany

  • Research Site

    Hamburg, 20246, Germany

  • Research Site

    Leipzig, 04103, Germany

  • Research Site

    München, 81675, Germany

  • Research Site

    Oldenburg, 26133, Germany

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Milan, 20133, Italy

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Rome, 00168, Italy

  • Research Site

    Rozzano, 20089, Italy

  • Research Site

    Torino, 10100, Italy

  • Research Site

    Oslo, 0450, Norway

  • Research Site

    Gdansk, 80-214, Poland

  • Research Site

    Gliwice, 44-100, Poland

  • Research Site

    Kielce, 25-734, Poland

  • Research Site

    Krakow, 30-688, Poland

  • Research Site

    Lublin, 20-090, Poland

  • Research Site

    Wroclaw, 50-556, Poland

  • Research Site

    Singapore, 119228, Singapore

  • Research Site

    Singapore, 169608, Singapore

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Seoul, 5505, South Korea

  • Research Site

    Badalona, 08916, Spain

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    El Palmar, 30120, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Salamanca, 37007, Spain

  • Research Site

    Santander, 39008, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Taipei, 106, Taiwan

  • Research Site

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    London, W12 0HS, United Kingdom

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