Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06413498

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

Led by Kite, A Gilead Company · Updated on 2026-05-07

450

Participants Needed

124

Research Sites

357 weeks

Total Duration

On this page

Sponsors

K

Kite, A Gilead Company

Lead Sponsor

A

Arcellx, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with multiple myeloma
  • Received 1 to 3 prior antimyeloma treatments including an immunomodulatory drug and an anti-CD38 monoclonal antibody
  • Evidence of disease progression within 12 months of last treatment
  • Measurable disease by serum or urine tests
  • Eligible for at least one of the four standard care regimens as per investigator
  • ECOG performance status of 0 or 1
  • Female participants of childbearing potential must have a negative pregnancy test
Not Eligible

You will not qualify if you...

  • Previous BCMA-targeted therapy
  • Previous T-cell engager therapy
  • Previous CAR or genetically modified T-cell therapy
  • Central nervous system or meningeal involvement of multiple myeloma
  • Cardiac atrial or ventricular involvement of multiple myeloma
  • History of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or amyloidosis
  • Active cancer other than multiple myeloma requiring treatment within last 24 months
  • Prior auto stem cell transplant within 12 weeks before study
  • Prior allogeneic stem cell transplant
  • High-dose systemic steroids or immunosuppressive therapy within 14 days before study
  • Live vaccine within 4 weeks before study
  • Contraindication to fludarabine or cyclophosphamide
  • Allergy or severe hypersensitivity to study drugs or components including DMSO
  • Life expectancy less than 12 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 124 locations

1

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

Active, Not Recruiting

2

Mayo Clinic Hospital

Gilbert, Arizona, United States, 85234

Active, Not Recruiting

3

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States, 91010

Active, Not Recruiting

4

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Active, Not Recruiting

5

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

Active, Not Recruiting

6

UC San Diego Moores Cancer Center

San Diego, California, United States, 92037

Active, Not Recruiting

7

University of California San Francisco Medical Center

San Francisco, California, United States, 94143

Withdrawn

8

UCLA Hematology/Oncology (Bowyer Infusion Clinic)

Santa Monica, California, United States, 90404

Active, Not Recruiting

9

Stanford Cancer Institute

Stanford, California, United States, 94305

Active, Not Recruiting

10

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

Active, Not Recruiting

11

Sylvester Comprehensive Cancer Center

Coral Gables, Florida, United States, 33146

Active, Not Recruiting

12

Mayo Clinic

Jacksonville, Florida, United States, 32256

Active, Not Recruiting

13

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Active, Not Recruiting

14

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

Active, Not Recruiting

15

Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta

Newnan, Georgia, United States, 30265

Active, Not Recruiting

16

St. Luke's Cancer Institute

Boise, Idaho, United States, 83712

Active, Not Recruiting

17

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, United States, 60612

Active, Not Recruiting

18

IU Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States, 46202

Active, Not Recruiting

19

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, United States, 40207

Active, Not Recruiting

20

Ochsner Clinical Foundation

New Orleans, Louisiana, United States, 70121

Active, Not Recruiting

21

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

Active, Not Recruiting

22

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Active, Not Recruiting

23

Boston Medical Center

Boston, Massachusetts, United States, 02118

Active, Not Recruiting

24

University of Michigan

Ann Arbor, Michigan, United States, 48109

Active, Not Recruiting

25

Corewell Health - Lemmen-Holton Cancer Pavilion

Grand Rapids, Michigan, United States, 49503

Active, Not Recruiting

26

Mayo Clinic

Rochester, Minnesota, United States, 55902

Active, Not Recruiting

27

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy

Omaha, Nebraska, United States, 68130

Active, Not Recruiting

28

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Active, Not Recruiting

29

New Mexico Cancer Research Alliance

Albuquerque, New Mexico, United States, 87102

Active, Not Recruiting

30

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States, 10016

Active, Not Recruiting

31

Weill Cornell Medicine - New York Presbyterian Hosptial

New York, New York, United States, 10021

Active, Not Recruiting

32

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Active, Not Recruiting

33

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

Actively Recruiting

34

Novant Health Cancer Institute - Hematology

Charlotte, North Carolina, United States, 28204

Active, Not Recruiting

35

Novant Health Cancer Institute Hematology- Forsyth

Winston-Salem, North Carolina, United States, 27103

Active, Not Recruiting

36

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States, 45219

Active, Not Recruiting

37

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States, 45236

Active, Not Recruiting

38

Oregon Health and Science University

Portland, Oregon, United States, 97239

Active, Not Recruiting

39

University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

Active, Not Recruiting

40

Baptist Cancer Center

Memphis, Tennessee, United States, 38104

Active, Not Recruiting

41

Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research

Nashville, Tennessee, United States, 37203

Active, Not Recruiting

42

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States, 37232

Active, Not Recruiting

43

St. David's South Austin Medical Center

Austin, Texas, United States, 78704

Active, Not Recruiting

44

Houston Methodist Hospital Cancer Center

Houston, Texas, United States, 77030

Active, Not Recruiting

45

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Active, Not Recruiting

46

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States, 84112

Active, Not Recruiting

47

LDS Hospital

Salt Lake City, Utah, United States, 84143

Active, Not Recruiting

48

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Active, Not Recruiting

49

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Active, Not Recruiting

50

West Virginia University

Morgantown, West Virginia, United States, 26506

Active, Not Recruiting

51

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, NSW 2050

Active, Not Recruiting

52

Royal North Shore Hospital

St Leonards, New South Wales, Australia, 2065

Active, Not Recruiting

53

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Active, Not Recruiting

54

Epworth HealthCare

Richmond, Victoria, Australia, 3121

Active, Not Recruiting

55

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia, 6009

Active, Not Recruiting

56

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

Linz, Austria

Active, Not Recruiting

57

Paracelsus Medizinischen Privatuniversitaet

Salzburg, Austria, A-5020

Active, Not Recruiting

58

University Hospital St. Poelten, Department of Internal Medicine I

Sankt Pölten, Austria, 3100

Active, Not Recruiting

59

Medical University of Vienna

Vienna, Austria, 1090

Active, Not Recruiting

60

Cliniques Universitaires Saint-Luc

Brussels, Belgium, 1200

Active, Not Recruiting

61

University Hospital of Antwerp

Edegem, Belgium

Active, Not Recruiting

62

UZ Leuven

Flemish Brabant, Belgium, 3000

Active, Not Recruiting

63

UZ Gent

Gent Oost-Vlaanderen, Belgium, 9000

Active, Not Recruiting

64

QEII Health Sciences Centre

Halifax, Canada, B3H 2Y9

Active, Not Recruiting

65

McGill University Health Center

Montreal, Canada, H4A 3J1

Active, Not Recruiting

66

The Ottawa Hospital - General Campus

Ottawa, Canada, K1H 8L6

Active, Not Recruiting

67

University Health Network - The Princess Margaret Cancer Centre

Toronto, Canada, M5G 2M9

Active, Not Recruiting

68

Fakultni Nemocnice Ostrava

Severomoravsky KRAJ, Czechia, 708 52

Active, Not Recruiting

69

CHU de Lille- Hopital Claude Huriez

Lille, France, 59037

Active, Not Recruiting

70

Institut Paoli Calmettes

Marseille, France, 13273

Active, Not Recruiting

71

CHU De Montpellier - Hopital Saint Eloi

Montpellier, France, 34080

Active, Not Recruiting

72

Centre Hospitalier Universitaire de Nantes

Nantes, France, 44093

Active, Not Recruiting

73

Hopital Saint Louis

Paris, France, 75010

Active, Not Recruiting

74

Hopital Saint Antoine

Paris, France, 75571

Active, Not Recruiting

75

Hôpital Lyon Sud

Pierre-Bénite, France, 69495

Active, Not Recruiting

76

Centre Hospitalier Universitaire de Poitiers

Poitiers, France, 86021

Active, Not Recruiting

77

CHU de Rennes

Rennes, France, 59037

Active, Not Recruiting

78

CHU de Toulouse. IUCT Oncopole

Toulouse, France, 31100

Active, Not Recruiting

79

Charité - Universitätsmedizin Berlin

Berlin, Germany, 12203

Actively Recruiting

80

Universitatsklinikum Koln, Klinik I fOr lnnere Medizin

Cologne, Germany

Actively Recruiting

81

Universitätsklinikum Essen

Essen, Germany

Actively Recruiting

82

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany, 79106

Actively Recruiting

83

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany, 20246

Actively Recruiting

84

Universitatsklinikum Leipzig

Leipzig, Germany, 4103

Actively Recruiting

85

TUM Klinikum, Rechts der Isar, Klinik und Poliklinik fur Innere Medizin III, Hamatologie und Onkologie

München, Germany, 80333

Actively Recruiting

86

Universitatsklinikum Wurzburg

Tübingen, Germany, 72076

Actively Recruiting

87

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, MI, Italy, 20133

Active, Not Recruiting

88

IRCCS AOU di Bologna

Bologna, Italy, 40138

Active, Not Recruiting

89

Ospedale San Raffaele

Milan, Italy, 3302

Active, Not Recruiting

90

Policlinico Universitario Argostino Gemelli

Roma, Italy, 00168

Active, Not Recruiting

91

AOU Città della Salute e della Scienza Presidio Ospedaliero Molinette

Torino, Italy, 10126

Active, Not Recruiting

92

Hyogo Medical University Hospital

Hyōgo, Japan, 663-8501

Active, Not Recruiting

93

Nagoya City University Hospital

Nagoya, Japan, 467-8602

Active, Not Recruiting

94

The University of Osaka Hospital

Osaka, Japan, 565-0871

Active, Not Recruiting

95

Hamamatsu University Hospital

Shizuoka, Japan, 431-3192

Active, Not Recruiting

96

Jichi Medical University Hospital

Tochigi, Japan, 329-0498

Active, Not Recruiting

97

Juntendo University School of Medicine Juntendo Clinic

Tokyo, Japan, 113-8431

Active, Not Recruiting

98

Japanese Red Cross Medical Center

Tokyo, Japan, 150-8935

Active, Not Recruiting

99

Amsterdam UMC - Location vUmc

Amsterdam, Netherlands, 1081 HV

Active, Not Recruiting

100

University Medical Center Groningen

Groningen, Netherlands, 9700 RB

Active, Not Recruiting

101

Erasmus Medical Center

Rotterdam, Netherlands, 3015GD

Active, Not Recruiting

102

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland, 60-569

Active, Not Recruiting

103

Warszawa-Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, Poland, 02-097

Active, Not Recruiting

104

Instytut Hematologii i Transfuzjologii

Warsaw, Poland, 02-776

Active, Not Recruiting

105

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Poland, 50-367

Active, Not Recruiting

106

ICO Badalona-H.U. Germans Trias i Pujol

Badalona, Spain, 08916

Active, Not Recruiting

107

Hospital Clínic de Barcelona

Barcelona, Spain, 08036

Active, Not Recruiting

108

Hospital Duran i Reynals

Barcelona, Spain, 08908

Active, Not Recruiting

109

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Spain, 30120

Active, Not Recruiting

110

Hospital Universitario Ramon Y Cajal

Madrid, Spain, 28034

Active, Not Recruiting

111

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Active, Not Recruiting

112

Clinica Universidad de Navarra

Pamplona, Spain, 31008

Active, Not Recruiting

113

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain, 37007

Active, Not Recruiting

114

Hospital Universitario Marqués de Valdecilla

Santander, Spain, 39008

Active, Not Recruiting

115

Hospital Universitario Virgen del Rocio

Seville, Spain, 41013

Active, Not Recruiting

116

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain, 46026

Active, Not Recruiting

117

Inselspital - Universitätsspital Bern

Bern, Switzerland, 3010

Active, Not Recruiting

118

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland, CH-1011

Active, Not Recruiting

119

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

Bristol, United Kingdom, BS2 8ED

Active, Not Recruiting

120

University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW

Active, Not Recruiting

121

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

Leeds, United Kingdom, LS9 7TF

Active, Not Recruiting

122

King's College Hospital

London, United Kingdom, SE5 9NU

Active, Not Recruiting

123

University College London Hospital

London, United Kingdom, WC1E 6JN

Active, Not Recruiting

124

Newcastle Hospitals NHS Foundation Trust, Freeman Hospital

Newcastle, United Kingdom, NE7 7DN

Active, Not Recruiting

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Research Team

M

Medical Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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