A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
NCT ID: NCT06413498
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2024-08-23
2031-07-31
Brief Summary
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The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Anitocabtagene Autoleucel
Participants with RRMM will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for 3 days followed by single dose of anitocabtagene autoleucel chimeric antigen receptor positive (CAR+) on Day 1.
Anitocabtagene Autoleucel
A single infusion of CAR+ transduced autologous T cells
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Standard of Care Therapy (SOCT)
Participants will receive the investigator's choice of one of the following therapies:
* pomalidomide, bortezomib, and dexamethasone (PVd) (21-day cycles)
* daratumumab, pomalidomide, and dexamethasone (DPd) (28-day cycles)
* carfilzomib, daratumumab, and dexamethasone (KDd) (28-day cycles)
* carfilzomib and dexamethasone (Kd) (28-day cycles)
Pomalidomide
Tablet administered orally
Bortezomib
Administered intravenously or subcutaneously
Dexamethasone
Tablet administered orally
Daratumumab
Administered intravenously or subcutaneously
Carfilzomib
Administered intravenously
Interventions
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Anitocabtagene Autoleucel
A single infusion of CAR+ transduced autologous T cells
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Pomalidomide
Tablet administered orally
Bortezomib
Administered intravenously or subcutaneously
Dexamethasone
Tablet administered orally
Daratumumab
Administered intravenously or subcutaneously
Carfilzomib
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Arcellx, Inc.
INDUSTRY
Kite, A Gilead Company
INDUSTRY
Responsible Party
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Principal Investigators
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Kite Study Director
Role: STUDY_DIRECTOR
Kite, A Gilead Company
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
UC San Diego Moores Cancer Center
San Diego, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
UCLA Department of Medicine-Hematology/Oncology
Santa Monica, California, United States
Stanford Cancer Institute
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
Newnan, Georgia, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States
IU Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Corewell Health - Lemmen-Holton Cancer Pavilion
Grand Rapids, Michigan, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Weill Cornell Medicine - New York Presbyterian Hosptial
New York, New York, United States
Novant Health Cancer Institute Hematology
Charlotte, North Carolina, United States
Novant Health Cancer Institute Hematology- Forsyth
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Houston Methodist Hospital Cancer Center
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Swedish Cancer Institute
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Epworth HealthCare
Richmond, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen, Hamatologie mit Stammzelltransplantation, Hamostaseologie und medizinische Onkologie
Linz, , Austria
Paracelsus Medizinischen Privatuniversitaet
Salzburg, , Austria
University Hospital St. Poelten, Department of Internal Medicine I
Sankt Pölten, , Austria
Medical University of Vienna
Vienna, , Austria
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
University Hospital of Antwerp
Edegem, , Belgium
UZ Leuven
Flemish Brabant, , Belgium
UZ Gent
Gent Oost-Vlaanderen, , Belgium
QEII Health Sciences Centre
Halifax, , Canada
McGill University Health Center
Montreal, , Canada
University Health Network - The Princess Margaret Cancer Centre
Toronto, , Canada
Fakultni Nemocnice Ostrava
Severomoravsky KRAJ, , Czechia
CHU de Lille- Hopital Claude Huriez
Lille, , France
Institut Paoli Calmettes
Marseille, , France
CHU De Montpellier - Hopital Saint Eloi
Montpellier, , France
Centre Hospitalier Universitaire de Nantes
Nantes, , France
Hopital Saint Louis
Paris, , France
Hopital Saint Antoine
Paris, , France
Hôpital Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
CHU de Rennes
Rennes, , France
CHU de Toulouse. IUCT Oncopole
Toulouse, , France
Universitatsklinikum Koln, Klinik I fOr lnnere Medizin
Cologne, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
TUM Klinikum, Rechts der Isar, Klinik und Poliklinik fur Innere Medizin III, Hamatologie und Onkologie
München, , Germany
Universitatsklinikum Wurzburg
Tübingen, , Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy
IRCCS AOU di Bologna
Bologna, , Italy
Ospedale San Raffaele
Milan, , Italy
AOU Città della Salute e della Scienza Presidio Ospedaliero Molinette
Torino, , Italy
Hyogo Medical University Hospital
Hyōgo, , Japan
Nagoya City University Hospital
Nagoya, , Japan
The University of Osaka Hospital
Osaka, , Japan
Hamamatsu University Hospital
Shizuoka, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
Juntendo University School of Medicine Juntendo Clinic
Tokyo, , Japan
Japanese Red Cross Medical Center
Tokyo, , Japan
Amsterdam UMC - Location vUmc
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Warszawa-Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, , Poland
ICO Badalona-H.U. Germans Trias i Pujol
Badalona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Duran i Reynals
Barcelona, , Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Inselspital - Universitätsspital Bern
Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds, , United Kingdom
King's College Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Newcastle Hospitals NHS Foundation Trust, Freeman Hospital
Newcastle, , United Kingdom
Countries
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Central Contacts
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2024-511188-26
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2043240170
Identifier Type: OTHER
Identifier Source: secondary_id
KT-US-679-0788
Identifier Type: -
Identifier Source: org_study_id