NCT06413498

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Anitocabtagene Autoleucel	A single infusion of CAR+ transduced autologous T cells
DRUG	Cyclophosphamide	Administered intravenously
DRUG	Fludarabine	Administered intravenously
DRUG	Pomalidomide	Tablet administered orally
DRUG	Bortezomib	Administered intravenously or subcutaneously
DRUG	Dexamethasone	Tablet administered orally
DRUG	Daratumumab	Administered intravenously or subcutaneously
DRUG	Carfilzomib	Administered intravenously

Timeline

• Start date: 2024-08-23
• Primary completion: 2028-07-01
• Completion: 2031-07-01
• First posted: 2024-05-14
• Last updated: 2026-03-27

Locations

124 sites across 15 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Italy, Japan, Netherlands, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study