A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
iMMagine-3
A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma
3 other identifiers
interventional
452
14 countries
112
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-myeloma
Started Aug 2024
Typical duration for phase_3 multiple-myeloma
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2024
CompletedFirst Posted
Study publicly available on registry
May 14, 2024
CompletedStudy Start
First participant enrolled
August 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2031
July 29, 2026
July 1, 2026
3.9 years
May 9, 2024
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to disease progression per International Myeloma Working Group (IMWG) criteria as determined by independent review committee (IRC), or death due to any cause, whichever occurs first.
Up to 4 years
Minimal Residual Disease (MRD) Complete Response (CR) Rate at 9 Months
Minimal MRD is defined as the proportion of participants achieving CR/stringent CR (sCR) and MRD-negative status at 9 months. MRD negativity at 9 months is defined as negative MRD value at 9 months (± 3 months) in bone marrow assessment (\< 1 in 105 nucleated cells per IMWG criteria using NGS) (Kumar 2016). CR/sCR per IMWG criteria is determined by IRC.
Up to 9 months
Secondary Outcomes (17)
CR Rate (CR/ Stringent Complete Response (sCR))
Up to 4 years
Overall MRD Negativity
Up to 7 years
Overall survival (OS)
Up to 7 years
Overall Response Rate (ORR)
Up to 7 years
MRD-negative CR/sCR
Up to 7 years
- +12 more secondary outcomes
Study Arms (2)
Anitocabtagene Autoleucel
EXPERIMENTALParticipants 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.
Standard of Care Therapy (SOCT)
ACTIVE COMPARATORParticipants 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)
Interventions
A single infusion of CAR+ transduced autologous T cells
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kite, A Gilead Companylead
- Arcellx, Inc.collaborator
Study Sites (117)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Mayo Clinic Hospital
Gilbert, Arizona, 85234, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, 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
Stanford Cancer Institute
Stanford, California, 94305, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Sylvester Comprehensive Cancer Center
Coral Gables, Florida, 33146, United States
Mayo Clinic
Jacksonville, Florida, 32256, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
Newnan, Georgia, 30265, United States
St. Luke's Cancer Institute
Boise, Idaho, 83712, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612, United States
IU Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207, United States
Ochsner Clinical Foundation
New Orleans, Louisiana, 70121, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Corewell Health - Lemmen-Holton Cancer Pavilion
Grand Rapids, Michigan, 49503, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
Omaha, Nebraska, 68130, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
New Mexico Cancer Research Alliance
Albuquerque, New Mexico, 87102, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
Weill Cornell Medicine - New York Presbyterian Hosptial
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Novant Health Cancer Institute Hematology- Forsyth
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45219, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Baptist Cancer Center
Memphis, Tennessee, 38104, United States
Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research
Nashville, Tennessee, 37203, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
St. David's South Austin Medical Center
Austin, Texas, 78704, United States
Houston Methodist Hospital Cancer Center
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, NSW 2050, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Epworth HealthCare
Richmond, Victoria, 3121, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Ordensklinikum Linz GmbH Elisabethinen, Hamatologie mit Stammzelltransplantation, Hamostaseologie und medizinische Onkologie
Linz, Austria
Paracelsus Medizinischen Privatuniversitaet
Salzburg, A-5020, Austria
University Hospital St. Poelten, Department of Internal Medicine I
Sankt Pölten, 3100, Austria
Medical University of Vienna
Vienna, 1090, Austria
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
University Hospital of Antwerp
Edegem, Belgium
UZ Leuven
Flemish Brabant, 3000, Belgium
UZ Gent
Gent Oost-Vlaanderen, 9000, Belgium
QEII Health Sciences Centre
Halifax, B3H 2Y9, Canada
McGill University Health Center
Montreal, H4A 3J1, Canada
The Ottawa Hospital - General Campus
Ottawa, K1H 8L6, Canada
University Health Network - The Princess Margaret Cancer Centre
Toronto, M5G 2M9, Canada
Fakultni Nemocnice Ostrava
Severomoravsky KRAJ, 708 52, Czechia
CHU de Lille- Hopital Claude Huriez
Lille, 59037, France
Institut Paoli Calmettes
Marseille, 13273, France
CHU De Montpellier - Hopital Saint Eloi
Montpellier, 34080, France
Centre Hospitalier Universitaire de Nantes
Nantes, 44093, France
Hopital Saint Louis
Paris, 75010, France
Hopital Saint Antoine
Paris, 75571, France
Hôpital Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
CHU de Rennes
Rennes, 59037, France
CHU de Toulouse. IUCT Oncopole
Toulouse, 31100, France
Charité - Universitätsmedizin Berlin
Berlin, 12203, Germany
Universitatsklinikum Koln, Klinik I fOr lnnere Medizin
Cologne, Germany
Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Universitatsklinikum Leipzig
Leipzig, 4103, Germany
TUM Klinikum, Rechts der Isar, Klinik und Poliklinik fur Innere Medizin III, Hamatologie und Onkologie
München, 80333, Germany
Universitatsklinikum Wurzburg
Tübingen, 72076, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, 20133, Italy
IRCCS AOU di Bologna
Bologna, 40138, Italy
Ospedale San Raffaele
Milan, 3302, Italy
Policlinico Universitario Argostino Gemelli
Roma, 00168, Italy
AOU Città della Salute e della Scienza Presidio Ospedaliero Molinette
Torino, 10126, Italy
Hyogo Medical University Hospital
Hyōgo, 663-8501, Japan
Nagoya City University Hospital
Nagoya, 467-8602, Japan
The University of Osaka Hospital
Osaka, 565-0871, Japan
Jichi Medical University Hospital
Tochigi, 329-0498, Japan
Juntendo University School of Medicine Juntendo Clinic
Tokyo, 113-8431, Japan
Japanese Red Cross Medical Center
Tokyo, 150-8935, Japan
Amsterdam UMC - Location vUmc
Amsterdam, 1081 HV, Netherlands
University Medical Center Groningen
Groningen, 9700 RB, Netherlands
Erasmus Medical Center
Rotterdam, 3015GD, Netherlands
Warszawa-Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, 02-097, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, 50-367, Poland
ICO Badalona-H.U. Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, 30120, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Clinica Universidad de Navarra
Pamplona, 31008, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Inselspital - Universitätsspital Bern
Bern, 3010, Switzerland
University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds, LS9 7TF, United Kingdom
King's College Hospital
London, SE5 9NU, United Kingdom
University College London Hospital
London, WC1E 6JN, United Kingdom
Newcastle Hospitals NHS Foundation Trust, Freeman Hospital
Newcastle, NE7 7DN, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kite Study Director
Kite, A Gilead Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2024
First Posted
May 14, 2024
Study Start
August 23, 2024
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2031
Last Updated
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share