A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
A Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis (GMG). Anitocabtagene autoleucel (anito-cel) is a BCMA-directed CAR-T cell therapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subject must be 18 years of age or older
• Must have MGFA clinical classification Grades 2-4A at time of screening
• Subject must have clinically active disease and requiring ongoing therapy for GMG
• MG-ADL score 6 and QMG score \>10 at screening
• GMG specific autoantibodies must be above the reference laboratory ULN
Locations
United States
California
UCLA Medical Center
RECRUITING
Los Angeles
University of California, Irvine
RECRUITING
Orange
Stanford Hospital
RECRUITING
Palo Alto
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
New York
Columbia University Irving Medical Center
RECRUITING
New York
Ohio
Ohio State University
RECRUITING
Columbus
Oregon
Oregon Health & Science University (OHSU)
RECRUITING
Portland
Pennsylvania
Temple University Hospital
RECRUITING
Philadelphia
Texas
Houston Methodist Hospital
RECRUITING
Houston
Contact Information
Primary
Clinical Information
clinical@arcellx.com
240-327-0379
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2028-04
Participants
Target number of participants: 30
Treatments
Experimental: anito-cel
Single dose of anito-cel cells infused intravenously
Related Therapeutic Areas
Sponsors
Leads: Arcellx, Inc.