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New cell therapy shows promise in battle against Hard-to-Treat multiple myeloma

NCT ID NCT06413498

Disease control Sponsor: Kite, A Gilead Company 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 4 times

Summary

This study tests a new treatment called anitocabtagene autoleucel (a type of cell therapy) against standard treatments for people with multiple myeloma that has returned or not responded to 1-3 prior therapies. About 450 participants will be randomly assigned to receive either the new cell therapy or standard care. The main goal is to see which approach better delays cancer progression and reduces signs of the disease in the bone marrow.

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

452 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Jul 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.

Key Inclusion Criteria: * Documented historical diagnosis of multiple myeloma (MM) * Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy. * Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen * Measurable disease at screening per IMWG, defined as any of the following: * Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or * Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio * Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) Key Exclusion Criteria: * Prior B-cell maturation antigen (BCMA)-targeted therapy * Prior T-cell engager therapy * Prior CAR therapy or other genetically modified T-cell therapy * Active or prior history of central nervous system (CNS) or meningeal involvement of MM * Cardiac atrial or cardiac ventricular MM involvement * History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis * Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted. * Prior auto-SCT within 12 weeks before randomization * Prior allogeneic stem cell transplant (allo-SCT) * High-dose (eg, cumulative \> 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization * Live vaccine ≤ 4 weeks before randomization * Contraindication to fludarabine or cyclophosphamide * History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded. * Life expectancy \< 12 weeks Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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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.

Multiple myeloma

Contacts and locations

Locations

  • AOU Città della Salute e della Scienza Presidio Ospedaliero Molinette

    Torino, 10126, Italy

  • Amsterdam UMC - Location vUmc

    Amsterdam, 1081 HV, Netherlands

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Baptist Cancer Center

    Memphis, Tennessee, 38104, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • CHU De Montpellier - Hopital Saint Eloi

    Montpellier, 34080, France

  • CHU de Lille- Hopital Claude Huriez

    Lille, 59037, France

  • CHU de Rennes

    Rennes, 59037, France

  • CHU de Toulouse. IUCT Oncopole

    Toulouse, 31100, France

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093, France

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021, France

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203, Germany

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007, Spain

  • Corewell Health - Lemmen-Holton Cancer Pavilion

    Grand Rapids, Michigan, 49503, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Epworth HealthCare

    Richmond, Victoria, 3121, Australia

  • Erasmus Medical Center

    Rotterdam, 3015GD, Netherlands

  • Fakultni Nemocnice Ostrava

    Severomoravsky KRAJ, 708 52, Czechia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI, 20133, Italy

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232, United States

  • Hopital Saint Antoine

    Paris, 75571, France

  • Hopital Saint Louis

    Paris, 75010, France

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, 30120, Spain

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Houston Methodist Hospital Cancer Center

    Houston, Texas, 77030, United States

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112, United States

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501, Japan

  • Hôpital Lyon Sud

    Pierre-Bénite, 69495, France

  • ICO Badalona-H.U. Germans Trias i Pujol

    Badalona, 08916, Spain

  • IRCCS AOU di Bologna

    Bologna, 40138, Italy

  • IU Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inselspital - Universitätsspital Bern

    Bern, 3010, Switzerland

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776, Poland

  • Japanese Red Cross Medical Center

    Tokyo, 150-8935, Japan

  • Jichi Medical University Hospital

    Tochigi, 329-0498, Japan

  • Juntendo University School of Medicine Juntendo Clinic

    Tokyo, 113-8431, Japan

  • King's College Hospital

    London, SE5 9NU, United Kingdom

  • LDS Hospital

    Salt Lake City, Utah, 84143, United States

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • Leeds Teaching Hospitals NHS Trust, St James's University Hospital

    Leeds, LS9 7TF, United Kingdom

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Jacksonville, Florida, 32256, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Mayo Clinic Hospital

    Gilbert, Arizona, 85234, United States

  • McGill University Health Center

    Montreal, H4A 3J1, Canada

  • Medical University of Vienna

    Vienna, 1090, Austria

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Nagoya City University Hospital

    Nagoya, 467-8602, Japan

  • New Mexico Cancer Research Alliance

    Albuquerque, New Mexico, 87102, United States

  • Newcastle Hospitals NHS Foundation Trust, Freeman Hospital

    Newcastle, NE7 7DN, United Kingdom

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky, 40207, United States

  • Novant Health Cancer Institute Hematology- Forsyth

    Winston-Salem, North Carolina, 27103, United States

  • Ochsner Clinical Foundation

    New Orleans, Louisiana, 70121, United States

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy

    Omaha, Nebraska, 68130, United States

  • Ordensklinikum Linz GmbH Elisabethinen, Hamatologie mit Stammzelltransplantation, Hamostaseologie und medizinische Onkologie

    Linz, Austria

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Ospedale San Raffaele

    Milan, 3302, Italy

  • Paracelsus Medizinischen Privatuniversitaet

    Salzburg, A-5020, Austria

  • Policlinico Universitario Argostino Gemelli

    Roma, 00168, Italy

  • QEII Health Sciences Centre

    Halifax, B3H 2Y9, Canada

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, NSW 2050, Australia

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta

    Newnan, Georgia, 30265, United States

  • St. David's South Austin Medical Center

    Austin, Texas, 78704, United States

  • St. Luke's Cancer Institute

    Boise, Idaho, 83712, United States

  • Stanford Cancer Institute

    Stanford, California, 94305, United States

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • Sylvester Comprehensive Cancer Center

    Coral Gables, Florida, 33146, United States

  • TUM Klinikum, Rechts der Isar, Klinik und Poliklinik fur Innere Medizin III, Hamatologie und Onkologie

    München, 80333, Germany

  • Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research

    Nashville, Tennessee, 37203, United States

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6, Canada

  • The University of Osaka Hospital

    Osaka, 565-0871, Japan

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UC San Diego Moores Cancer Center

    San Diego, California, 92037, United States

  • UCLA Hematology/Oncology (Bowyer Infusion Clinic)

    Santa Monica, California, 90404, United States

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • UZ Gent

    Gent Oost-Vlaanderen, 9000, Belgium

  • UZ Leuven

    Flemish Brabant, 3000, Belgium

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20246, Germany

  • Universitatsklinikum Koln, Klinik I fOr lnnere Medizin

    Cologne, Germany

  • Universitatsklinikum Leipzig

    Leipzig, 4103, Germany

  • Universitatsklinikum Wurzburg

    Tübingen, 72076, Germany

  • University College London Hospital

    London, WC1E 6JN, United Kingdom

  • University Health Network - The Princess Margaret Cancer Centre

    Toronto, M5G 2M9, Canada

  • University Hospital St. Poelten, Department of Internal Medicine I

    Sankt Pölten, 3100, Austria

  • University Hospital of Antwerp

    Edegem, Belgium

  • University Hospital of Wales

    Cardiff, CF14 4XW, United Kingdom

  • University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED, United Kingdom

  • University Medical Center Groningen

    Groningen, 9700 RB, Netherlands

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45219, United States

  • University of Illinois Hospital and Health Sciences System

    Chicago, Illinois, 60612, United States

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • Universitätsklinikum Essen

    Essen, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, 50-367, Poland

  • Warszawa-Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw, 02-097, Poland

  • Weill Cornell Medicine - New York Presbyterian Hosptial

    New York, New York, 10021, United States

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.