LAST UPDATED
July 29, 2026
Clinicaltrials.gov ID
CTSID
CTSID
OVERVIEW
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 (iMMagine-3)
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Multiple Myeloma
Gender
N/A
Date
August 2024 - July 2028
Study Type
Interventional
Study Phase
Phase 3
Product
Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib, Dexamethasone, Daratumumab, Carfilzomib
Eligibility information
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)
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.
Locations
Locations (117)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
UC San Diego Moores Cancer Center
San Diego, California, United States, 92037
UCLA Hematology/Oncology (Bowyer Infusion Clinic)
Santa Monica, California, United States, 90404
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Sylvester Comprehensive Cancer Center
Coral Gables, Florida, United States, 33146
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
Newnan, Georgia, United States, 30265
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States, 60612
IU Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States, 40207
Ochsner Clinical Foundation
New Orleans, Louisiana, United States, 70121
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Corewell Health - Lemmen-Holton Cancer Pavilion
Grand Rapids, Michigan, United States, 49503
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
Omaha, Nebraska, United States, 68130
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
New Mexico Cancer Research Alliance
Albuquerque, New Mexico, United States, 87102
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Weill Cornell Medicine - New York Presbyterian Hosptial
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Novant Health Cancer Institute Hematology- Forsyth
Winston-Salem, North Carolina, United States, 27103
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States, 45219
Oregon Health and Science University
Portland, Oregon, United States, 97239
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research
Nashville, Tennessee, United States, 37203
St. David's South Austin Medical Center
Austin, Texas, United States, 78704
Houston Methodist Hospital Cancer Center
Houston, Texas, United States, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, NSW 2050
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Ordensklinikum Linz GmbH Elisabethinen, Hamatologie mit Stammzelltransplantation, Hamostaseologie und medizinische Onkologie
Linz, Austria,
Paracelsus Medizinischen Privatuniversitaet
Salzburg, Austria, A-5020
University Hospital St. Poelten, Department of Internal Medicine I
Sankt Pölten, Austria, 3100
University Health Network - The Princess Margaret Cancer Centre
Toronto, Canada, M5G 2M9
Universitatsklinikum Koln, Klinik I fOr lnnere Medizin
Cologne, Germany,
TUM Klinikum, Rechts der Isar, Klinik und Poliklinik fur Innere Medizin III, Hamatologie und Onkologie
München, Germany, 80333
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy, 20133
AOU Città della Salute e della Scienza Presidio Ospedaliero Molinette
Torino, Italy, 10126
Juntendo University School of Medicine Juntendo Clinic
Tokyo, Japan, 113-8431
Warszawa-Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland, 02-097
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Poland, 50-367
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Spain, 30120
Complejo Asistencial Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Newcastle Hospitals NHS Foundation Trust, Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
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