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

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

NCT ID: NCT06413498

Condition: Multiple Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Cyclophosphamide
Fludarabine
Bortezomib
Daratumumab
Pomalidomide

Conditions: Keywords:
Multiple Myeloma
CAR-T
ddBCMA
BCMA

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Anitocabtagene Autoleucel
Description: A single infusion of CAR+ transduced autologous T cells
Arm group label: Anitocabtagene Autoleucel

Other name: CART-ddBCMA

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: Administered intravenously
Arm group label: Anitocabtagene Autoleucel

Intervention type: Drug
Intervention name: Fludarabine
Description: Administered intravenously
Arm group label: Anitocabtagene Autoleucel

Intervention type: Drug
Intervention name: Pomalidomide
Description: Tablet administered orally
Arm group label: Standard of Care Therapy (SOCT)

Intervention type: Drug
Intervention name: Bortezomib
Description: Administered intravenously or subcutaneously
Arm group label: Standard of Care Therapy (SOCT)

Intervention type: Drug
Intervention name: Dexamethasone
Description: Tablet administered orally
Arm group label: Standard of Care Therapy (SOCT)

Intervention type: Drug
Intervention name: Daratumumab
Description: Administered intravenously or subcutaneously
Arm group label: Standard of Care Therapy (SOCT)

Intervention type: Drug
Intervention name: Carfilzomib
Description: Administered intravenously
Arm group label: Standard of Care Therapy (SOCT)

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 as measured by progression-free survival (PFS) per blinded independent review committee (IRC).

Detailed description: After completing the treatment period, all participants who will receive anitocabtagene autoleucel, will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

Address:
City: New York
Zip: 10016
Country: United States

Status: Recruiting

Facility:
Name: University of Tennessee Medical Center

Address:
City: Knoxville
Zip: 37920
Country: United States

Status: Recruiting

Start date: August 23, 2024

Completion date: July 2031

Lead sponsor:
Agency: Kite, A Gilead Company
Agency class: Industry

Collaborator:
Agency: Arcellx, Inc.
Agency class: Industry

Source: Gilead Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06413498
https://www.gileadclinicaltrials.com/study?nctid=NCT06413498