New Dual-Targeting CAR-T therapy aims to outperform standard care in advanced myeloma

NCT ID NCT07391657

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 6 times

Summary

This study tests a new treatment called AZD0120, which uses a patient's own immune cells engineered to attack two targets (BCMA and CD19) on myeloma cells. It is for people whose multiple myeloma has returned or stopped responding to prior treatments. The study compares AZD0120 to standard drug combinations to see if it can delay cancer progression and achieve deeper remissions.

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 508 people

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

Started

Feb 2026

Expected to finish

Jul 2030

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: * Age ≥ 18 years * Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria * Documented evidence of measurable disease: 1. Serum M-protein level ≥ 1 g/dL 2. Urine M-protein level ≥ 200 mg/24h 3. Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio * Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy * Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy * Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator. * ECOG performance status score of 0 to 1 * Adequate hematology and chemistry laboratory values: 1. Haemoglobin ≥ 8.0 g/dL 2. Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3) 3. Platelet count ≥ 75 × 10\^9/L (75000 per mm3) in participants with \< 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10\^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells 4. Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L) 5. Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute 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, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome. * Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy) * Significant neurological or psychiatric condition * Significant medical condition that places the participant at an unacceptable risk for treatment-related complications * Previously received any prior BCMA-targeted treatment * Previously received CAR-T or CAR-NK therapy directed at any target * Previously received T-cell engager therapy directed at any target * Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

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

Relapsed/refractory multiple myeloma

How to take part

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

The places running it

128 sites in 15 countries. The list below names each one and where it is.
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 ↗
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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Gilbert, Arizona, 85234, United States
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Phoenix, Arizona, 85054, United States
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Tucson, Arizona, 85719, United States
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La Jolla, California, 92093, United States
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Sacramento, California, 95817, United States
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Santa Monica, California, 90404, United States
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Denver, Colorado, 80218, United States
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New Haven, Connecticut, 06510, United States
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Washington D.C., District of Columbia, 20007, United States
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Coral Gables, Florida, 33156, United States
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Tampa, Florida, 33606, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60612, United States
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Park Ridge, Illinois, 60068, United States
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Iowa City, Iowa, 52242, United States
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Kansas City, Kansas, 66160, United States
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Louisville, Kentucky, 40207, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02215, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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Rochester, Minnesota, 55905, United States
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Albany, New York, 12208, United States
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New York, New York, 10016, United States
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New York, New York, 10029, United States
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New York, New York, 10065, United States
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New York, New York, 10065, United States
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Rochester, New York, 14642, United States
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The Bronx, New York, 10467, United States
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Chapel Hill, North Carolina, 27514, United States
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Charlotte, North Carolina, 28204, United States
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Charlotte, North Carolina, 28204, United States
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Winston-Salem, North Carolina, 27103, United States
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Winston-Salem, North Carolina, 27157, United States
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Cincinnati, Ohio, 45220, United States
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Cleveland, Ohio, 44195, United States
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Portland, Oregon, 97239, United States
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Charleston, South Carolina, 29425, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78704, United States
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Dallas, Texas, 75235, United States
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Houston, Texas, 77030, United States
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Salt Lake City, Utah, 84112, United States
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Charlottesville, Virginia, 22908, United States
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Gainesville, Virginia, 20155, United States
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Richmond, Virginia, 23298, United States
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Puyallup, Washington, 98373, United States
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Seattle, Washington, 98104, United States
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Madison, Wisconsin, 53792, United States
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Milwaukee, Wisconsin, 53226, United States
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Camperdown, 2050, Australia
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Darlinghurst, 2010, Australia
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Fitzroy, VIC3065, Australia
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Liverpool, 2170, Australia
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Melbourne, 3000, Australia
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Melbourne, 3004, Australia
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Murdoch, WA6150, Australia
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Salvador, 41253-190, Brazil
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São Paulo, 01509-900, Brazil
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São Paulo, 05652-900, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Beijing, 100024, China
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Beijing, 100044, China
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Changchun, 130021, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chongqing, 400030, China
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Guangzhou, 510000, China
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Guangzhou, 510700, China
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Hefei, 230601, China
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Nanchang, 330000, China
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Nanchang, 330006, China
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Nanjing, 210000, China
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Ningbo, 315040, China
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Shanghai, 200025, China
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Shanghai, 200065, China
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Shanghai, 201210, China
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Shenzhen, 518039, China
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Tianjin, 300020, China
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Wenzhou, 325000, China
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Wuhan, 430030, China
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Xi'an, 710004, China
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Xi'an, 710061, China
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Zhengzhou, 450000, China
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Zhengzhou, 450008, China
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Lille, 59037, France
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Nantes, 44093, France
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Paris, 75010, France
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Pierre-Bénite, 69495, France
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Poitiers, 86021, France
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Toulouse, 31059, France
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Berlin, 12200, Germany
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Dresden, 01307, Germany
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Erlangen, 91054, Germany
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Essen, 45147, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 20246, Germany
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Leipzig, 04103, Germany
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Mainz, 55131, Germany
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München, 81675, Germany
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Nuremberg, 90419, Germany
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Würzburg, 97080, Germany
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Bologna, 40138, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Naples, 80131, Italy
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Rozzano, 20089, Italy
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Torino, 10100, Italy
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Bunkyō City, 113-8431, Japan
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Kashiwa, 277-8577, Japan
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Kyoto, 602-8566, Japan
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Nagoya, 467-8602, Japan
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Shibuya-ku, 150-8935, Japan
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Shinjuku-ku, 160-8582, Japan
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Oslo, 0450, Norway
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Gdansk, 80-952, Poland
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Gliwice, 44-101, Poland
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Lublin, 20-090, Poland
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Poznan, 60-569, Poland
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Warsaw, 02-776, Poland
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Wroclaw, 50-367, Poland
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Seoul, 03080, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 5505, South Korea
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Barcelona, 08036, Spain
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Barcelona, 8035, Spain
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Madrid, 28041, Spain
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Pamplona, 31008, Spain
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Salamanca, 37007, Spain
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Santander, 39008, Spain
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Valencia, 46026, Spain
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Taipei, 10002, Taiwan
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Taipei, 106, Taiwan
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Taipei, 112, Taiwan
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Birmingham, B9 5SS, United Kingdom
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Bristol, BS2 8ED, United Kingdom
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Glasgow, Scotland, G12 0YN, United Kingdom
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London, SM2 5NG, United Kingdom

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