Anitocabtagene Autoleucel

Drug

Also known as: anito-cel

Drug Profile

Anitocabtagene autoleucel (anito-cel) is an investigational BCMA-directed CAR T-cell therapy for multiple myeloma developed by Kite and Arcellx. It has shown deep and durable responses in clinical studies and has entered late-stage regulatory review in the U.S. for relapsed/refractory disease. The program remains pre-approval pending FDA action.

Drug Class
BCMA-directed autologous CAR T-cell therapy
Approval Status
Investigational; FDA accepted BLA with PDUFA target date of December 23, 2026
Mechanism of Action
Engineered CAR T-cell therapy targeting BCMA, using a D-domain binder construct
Indications
  • \Relapsed or refractory multiple myeloma\

Related News

Related Clinical Trials

NCT ID Title Status Phase
NCT07045909

Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)

RECRUITING PHASE2
NCT06413498

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

RECRUITING PHASE3