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Clinical Trials in the UK / NCT06413498
Active, not recruiting Phase 3

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

NCT06413498 · tracked via the Priya Life Science UK tracker
Sponsor
Kite, A Gilead Company
Phase
Phase 3
Started
2024-08-23
Last updated
2026-07-29

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Anitocabtagene AutoleucelCyclophosphamideFludarabinePomalidomideBortezomibDexamethasoneDaratumumabCarfilzomib

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key 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) 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 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.

Primary outcome measure(s)

Trial sites (117)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona
Mayo Clinic Hospital Gilbert Arizona
City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Duarte California
USC/Norris Comprehensive Cancer Center Los Angeles California
University of California Davis Comprehensive Cancer Center Sacramento California
UC San Diego Moores Cancer Center San Diego California
UCLA Hematology/Oncology (Bowyer Infusion Clinic) Santa Monica California
Stanford Cancer Institute Stanford California
Colorado Blood Cancer Institute Denver Colorado
Sylvester Comprehensive Cancer Center Coral Gables Florida
Mayo Clinic Jacksonville Florida
Moffitt Cancer Center Tampa Florida
Winship Cancer Institute, Emory University Atlanta Georgia
Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta Newnan Georgia
St. Luke's Cancer Institute Boise Idaho
University of Illinois Hospital and Health Sciences System Chicago Illinois
IU Melvin and Bren Simon Comprehensive Cancer Center Indianapolis Indiana
Norton Cancer Institute, St. Matthews Campus Louisville Kentucky
Ochsner Clinical Foundation New Orleans Louisiana
University of Maryland Greenebaum Comprehensive Cancer Center Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
Boston Medical Center Boston Massachusetts
University of Michigan Ann Arbor Michigan
Corewell Health - Lemmen-Holton Cancer Pavilion Grand Rapids Michigan
Mayo Clinic Rochester Minnesota
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy Omaha Nebraska
Dartmouth Hitchcock Medical Center Lebanon New Hampshire
New Mexico Cancer Research Alliance Albuquerque New Mexico
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York New York
Weill Cornell Medicine - New York Presbyterian Hosptial New York New York
Icahn School of Medicine at Mount Sinai New York New York
Levine Cancer Institute Charlotte North Carolina
Novant Health Cancer Institute Hematology- Forsyth Winston-Salem North Carolina
University of Cincinnati Cancer Center Cincinnati Ohio
Oregon Health and Science University Portland Oregon
University of Tennessee Medical Center Knoxville Tennessee
Baptist Cancer Center Memphis Tennessee
Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research Nashville Tennessee
Henry-Joyce Cancer Clinic Nashville Tennessee
St. David's South Austin Medical Center Austin Texas

+ 77 more sites — see the full list on the official registry below.

On this site

📄 Darzalex (daratumumab) drug profile →

More Kite, A Gilead Company trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06413498 on ClinicalTrials.gov ↗ ← All trials in the UK