A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

Last updated: July 6, 2026
Sponsor: Kite, A Gilead Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Multiple Myeloma

Bone Neoplasm

Leukemia

Treatment

Cyclophosphamide

Dexamethasone

Anitocabtagene Autoleucel

Clinical Study ID

NCT06413498
KT-US-679-0788
jRCT2043240170
2024-511188-26
  • Ages > 18
  • All Genders

Study Summary

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug.

The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Documented historical diagnosis of multiple myeloma (MM)

  • Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatorydrug (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 anyprior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be fromthe same regimen in the prior line(s) of therapy.

  • Documented evidence of progressive disease by IMWG criteria based on theinvestigator's determination on or within 12 months of the last dose of the lastregimen

  • 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 freelight 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 forthis study

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Females of childbearing potential must have a negative serum or urine pregnancy testwith a sensitivity of at least 25 mIU/mL (females who have undergone surgicalsterilization or who have been postmenopausal for at least 2 years are notconsidered to be of childbearing potential)

Exclusion

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 ofMM

  • Cardiac atrial or cardiac ventricular MM involvement

  • History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMSsyndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skinchanges), or amyloidosis

  • Active malignancy (other than MM) requiring ongoing treatment for disease controlwithin 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 therapyor 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.

Study Design

Total Participants: 452
Treatment Group(s): 8
Primary Treatment: Cyclophosphamide
Phase: 3
Study Start date:
August 23, 2024
Estimated Completion Date:
July 31, 2031

Study Description

After completing the treatment period, all participants who will receive anitocabtagene autoleucel, will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years.

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales NSW 2050
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Epworth HealthCare

    Richmond, Victoria 3121
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

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

    Linz,
    Austria

    Site Not Available

  • Paracelsus Medizinischen Privatuniversitaet

    Salzburg, A-5020
    Austria

    Site Not Available

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

    Sankt Pölten, 3100
    Austria

    Site Not Available

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • University Hospital of Antwerp

    Edegem,
    Belgium

    Site Not Available

  • UZ Leuven

    Flemish Brabant, 3000
    Belgium

    Site Not Available

  • UZ Gent

    Gent Oost-Vlaanderen, 9000
    Belgium

    Site Not Available

  • McGill University Health Center

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Active - Recruiting

  • QEII Health Sciences Centre

    Halifax, B3H 2Y9
    Canada

    Site Not Available

  • McGill University Health Center

    Montreal, H4A 3J1
    Canada

    Site Not Available

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa 6094817, K1H 8L6
    Canada

    Active - Recruiting

  • University Health Network - The Princess Margaret Cancer Centre

    Toronto, M5G 2M9
    Canada

    Site Not Available

  • Fakultni Nemocnice Ostrava

    Severomoravsky KRAJ, 708 52
    Czechia

    Site Not Available

  • CHU de Lille- Hopital Claude Huriez

    Lille, 59037
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille, 13273
    France

    Site Not Available

  • CHU De Montpellier - Hopital Saint Eloi

    Montpellier, 34080
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093
    France

    Site Not Available

  • Hopital Saint Antoine

    Paris, 75571
    France

    Site Not Available

  • Hopital Saint Louis

    Paris, 75010
    France

    Site Not Available

  • Hopital Saint Louis

    Paris 2988507, 75010
    France

    Active - Recruiting

  • Hôpital Lyon Sud

    Pierre-Bénite, 69495
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • CHU de Rennes

    Rennes, 59037
    France

    Site Not Available

  • CHU de Toulouse. IUCT Oncopole

    Toulouse, 31100
    France

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203
    Germany

    Site Not Available

  • Universitatsklinikum Koln, Klinik I fOr lnnere Medizin

    Cologne,
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen,
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106
    Germany

    Site Not Available

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig, 4103
    Germany

    Site Not Available

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

    München, 80333
    Germany

    Site Not Available

  • Universitatsklinikum Wurzburg

    Tübingen, 72076
    Germany

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI 20133
    Italy

    Site Not Available

  • IRCCS AOU di Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milan, 3302
    Italy

    Site Not Available

  • Policlinico Universitario Argostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • AOU Città della Salute e della Scienza Presidio Ospedaliero Molinette

    Torino, 10126
    Italy

    Site Not Available

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501
    Japan

    Site Not Available

  • Nagoya City University Hospital

    Nagoya, 467-8602
    Japan

    Site Not Available

  • The University of Osaka Hospital

    Osaka, 565-0871
    Japan

    Site Not Available

  • Jichi Medical University Hospital

    Tochigi, 329-0498
    Japan

    Site Not Available

  • Japanese Red Cross Medical Center

    Tokyo, 150-8935
    Japan

    Site Not Available

  • Juntendo University School of Medicine Juntendo Clinic

    Tokyo, 113-8431
    Japan

    Site Not Available

  • Japanese Red Cross Medical Center

    Tokyo 1850147, 150-8935
    Japan

    Active - Recruiting

  • Amsterdam UMC - Location vUmc

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • University Medical Center Groningen

    Groningen, 9700 RB
    Netherlands

    Site Not Available

  • Erasmus Medical Center

    Rotterdam, 3015GD
    Netherlands

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569
    Poland

    Site Not Available

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776
    Poland

    Site Not Available

  • Warszawa-Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw, 02-097
    Poland

    Site Not Available

  • Warszawa-Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw 756135, 02-097
    Poland

    Active - Recruiting

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

    Badalona, 08916
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Duran i Reynals

    Barcelona, 08908
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona 3128760, 08036
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, 30120
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario Ramon Y Cajal

    Madrid 3117735, 28034
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Seville, 41013
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Inselspital - Universitätsspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

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

    Bristol, BS2 8ED
    United Kingdom

    Site Not Available

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

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

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, SE5 9NU
    United Kingdom

    Site Not Available

  • University College London Hospital

    London, WC1E 6JN
    United Kingdom

    Site Not Available

  • King's College Hospital

    London 2643743, SE5 9NU
    United Kingdom

    Active - Recruiting

  • Newcastle Hospitals NHS Foundation Trust, Freeman Hospital

    Newcastle, NE7 7DN
    United Kingdom

    Site Not Available

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Mayo Clinic Hospital

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Banner MD Anderson Cancer Center

    Gilbert 5295903, Arizona 5551752 85234
    United States

    Active - Recruiting

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

    Duarte, California 91010
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Site Not Available

  • UC San Diego Moores Cancer Center

    San Diego, California 92037
    United States

    Site Not Available

  • UCLA Hematology/Oncology (Bowyer Infusion Clinic)

    Santa Monica, California 90404
    United States

    Site Not Available

  • Stanford Cancer Institute

    Stanford, California 94305
    United States

    Site Not Available

  • City of Hope Medical Center

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • University of California, Davis Comprehensive Cancer Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • UCLA Department of Medicine-Hematology/Oncology

    Santa Monica 5393212, California 5332921 90404
    United States

    Active - Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center - Miami

    Coral Gables 4151871, Florida 4155751 33146
    United States

    Active - Recruiting

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

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

    Newnan, Georgia 30265
    United States

    Site Not Available

  • Winship Cancer Institute

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

  • St. Luke's Cancer Institute

    Boise, Idaho 83712
    United States

    Site Not Available

  • University of Illinois Hospital and Health Sciences System

    Chicago, Illinois 60612
    United States

    Site Not Available

  • IU Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Ochsner Clinical Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Corewell Health - Lemmen-Holton Cancer Pavilion

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Site Not Available

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

    Omaha, Nebraska 68130
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Active - Recruiting

  • New Mexico Cancer Research Alliance

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque 5454711, New Mexico 5481136 87102
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Weill Cornell Medicine - New York Presbyterian Hosptial

    New York, New York 10021
    United States

    Site Not Available

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Novant Health Cancer Institute - Hematology

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Novant Health Cancer Institute Hematology- Forsyth

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Novant Health Cancer Institute Hematology

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

  • Oncology Hematology Care Clinical Trials, LLC

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Oncology Hematology Care Clinical Trials, LLC

    Cincinnati 4508722, Ohio 5165418 45236
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Baptist Cancer Center

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee 37232
    United States

    Site Not Available

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

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Henry-Joyce Cancer Clinic

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • St. David's South Austin Medical Center

    Austin, Texas 78704
    United States

    Site Not Available

  • Houston Methodist Hospital Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist Hospital Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • LDS Hospital

    Salt Lake City, Utah 84143
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Active - Recruiting

  • LDS Hospital

    Salt Lake City 5780993, Utah 5549030 84143
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Site Not Available

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Site Not Available

  • Swedish Cancer Institute

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Active - Recruiting

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