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

Last updated: May 2, 2025
Sponsor: Kite, A Gilead Company
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Myeloma

Lymphoproliferative Disorders

Leukemia

Treatment

Cyclophosphamide

Dexamethasone

Anitocabtagene Autoleucel

Clinical Study ID

NCT06413498
KT-US-679-0788
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 as measured by progression-free survival (PFS) per blinded independent review committee (IRC).

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: 450
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

    Active - Recruiting

  • Royal North Shore Hospital

    St. Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Epworth HealthCare

    Richmond, Victoria 3121
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

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

    Linz,
    Austria

    Active - Recruiting

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

    St. Poelten, 3100
    Austria

    Active - Recruiting

  • UZ Leuven

    Flemish Brabant, 3000
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent Oost-Vlaanderen, 9000
    Belgium

    Active - Recruiting

  • CHU de Lille- Hopital Claude Huriez

    Lille, 59037
    France

    Active - Recruiting

  • Institut Paoli Calmettes

    Marseille, 13273
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021
    France

    Active - Recruiting

  • CHU de Rennes

    Rennes, 59037
    France

    Active - Recruiting

  • CHU de Toulouse. IUCT Oncopole

    Toulouse, 31100
    France

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI 20133
    Italy

    Active - Recruiting

  • IRCCS AOU di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

  • Hyogo Medical University Hospital

    Hyogo, 663-8501
    Japan

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, 30120
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Active - Recruiting

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

    Bristol, BS2 8ED
    United Kingdom

    Active - Recruiting

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

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • University College London Hospital

    London, WC1E 6JN
    United Kingdom

    Active - Recruiting

  • Newcastle Hospitals NHS Foundation Trust, Freeman Hospital

    Newcastle, NE7 7DN
    United Kingdom

    Active - Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • UC San Diego Moores Cancer Center

    San Diego, California 92037
    United States

    Active - Recruiting

  • University of California San Francisco Medical Center

    San Francisco, California 94143
    United States

    Active - Recruiting

  • UCLA Department of Medicine-Hematology/Oncology

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • UCLA Hematology/Oncology (Bowyer Infusion Clinic)

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Norton Cancer Institute, St. Matthews Campus

    Shelbyville, Kentucky 40065
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Corewell Health - Lemmen-Holton Cancer Pavilion

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Baptist Cancer Center

    Memphis, Tennessee 38104
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • LDS Hospital

    Salt Lake City, Utah 84143
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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