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Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases
Sponsor: Kite, A Gilead Company
Summary
The goal of this clinical study is to learn more about the study drug Anitocabtagene autoleucel (anito-cel), and its safety, tolerability, dosing, and preliminary effectiveness in participants with generalized myasthenia gravis (GMG). Anito-cel is a B-cell maturation antigen (BCMA)-directed CAR-T cell therapy. The primary objective of this study is to assess the safety profile, including any dose-limiting toxicity (DLT) and identification of a maximum tolerated dose (MTD) (if applicable), to support selection of the recommended Phase 2 dose (RP2D) of anito-cel when administered to participants with GMG.
Official title: A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-Oncology Plasma Cell-Related Diseases
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-04-30
Completion Date
2028-10
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
anito-cel
Anitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-Domain
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Locations (14)
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
Stanford Blood and Marrow Transplant
Palo Alto, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of South Florida - Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota Delaware Clinical Research Unit
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University Irving Medical Center
New York, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States