Phase
Condition
Multiple Myeloma
Lymphoproliferative Disorders
Leukemia
Treatment
Cyclophosphamide
Dexamethasone
Anitocabtagene Autoleucel
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Royal Prince Alfred Hospital
Camperdown, New South Wales NSW 2050
AustraliaActive - Recruiting
Royal North Shore Hospital
St. Leonards, New South Wales 2065
AustraliaActive - Recruiting
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Epworth HealthCare
Richmond, Victoria 3121
AustraliaActive - Recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Ordensklinikum Linz GmbH Elisabethinen, Hamatologie mit Stammzelltransplantation, Hamostaseologie und medizinische Onkologie
Linz,
AustriaActive - Recruiting
University Hospital St. Poelten, Department of Internal Medicine I
St. Poelten, 3100
AustriaActive - Recruiting
UZ Leuven
Flemish Brabant, 3000
BelgiumActive - Recruiting
UZ Gent
Gent Oost-Vlaanderen, 9000
BelgiumActive - Recruiting
CHU de Lille- Hopital Claude Huriez
Lille, 59037
FranceActive - Recruiting
Institut Paoli Calmettes
Marseille, 13273
FranceActive - Recruiting
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
FranceActive - Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
FranceActive - Recruiting
CHU de Rennes
Rennes, 59037
FranceActive - Recruiting
CHU de Toulouse. IUCT Oncopole
Toulouse, 31100
FranceActive - Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI 20133
ItalyActive - Recruiting
IRCCS AOU di Bologna
Bologna, 40138
ItalyActive - Recruiting
Hyogo Medical University Hospital
Hyogo, 663-8501
JapanActive - Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, 30120
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Ramon Y Cajal
Madrid, 28034
SpainActive - Recruiting
Clinica Universidad de Navarra
Pamplona, 31008
SpainActive - Recruiting
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, 39008
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
SpainActive - Recruiting
University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
United KingdomActive - Recruiting
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds, LS9 7TF
United KingdomActive - Recruiting
University College London Hospital
London, WC1E 6JN
United KingdomActive - Recruiting
Newcastle Hospitals NHS Foundation Trust, Freeman Hospital
Newcastle, NE7 7DN
United KingdomActive - Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United StatesActive - Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesActive - Recruiting
UC San Diego Moores Cancer Center
San Diego, California 92037
United StatesActive - Recruiting
University of California San Francisco Medical Center
San Francisco, California 94143
United StatesActive - Recruiting
UCLA Department of Medicine-Hematology/Oncology
Santa Monica, California 90404
United StatesActive - Recruiting
UCLA Hematology/Oncology (Bowyer Infusion Clinic)
Santa Monica, California 90404
United StatesActive - Recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United StatesActive - Recruiting
Winship Cancer Institute
Atlanta, Georgia 30322
United StatesActive - Recruiting
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky 40207
United StatesActive - Recruiting
Norton Cancer Institute, St. Matthews Campus
Shelbyville, Kentucky 40065
United StatesSite Not Available
Boston Medical Center
Boston, Massachusetts 02118
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Corewell Health - Lemmen-Holton Cancer Pavilion
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Oregon Health and Science University
Portland, Oregon 97239
United StatesActive - Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United StatesActive - Recruiting
Baptist Cancer Center
Memphis, Tennessee 38104
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesActive - Recruiting
LDS Hospital
Salt Lake City, Utah 84143
United StatesActive - Recruiting
Swedish Cancer Institute
Seattle, Washington 98104
United StatesActive - Recruiting
University of Washington Medical Center
Seattle, Washington 98109
United StatesActive - Recruiting
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