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RECRUITINGPhase 1INTERVENTIONAL

A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Subject is pregnant or breastfeeding - Treatment with Anti-CD20 agents, calcineurin inhibitors, FcRN inhibitors, azathioprine, mycophenolate mofetil, methotrexate, or cyclophosphamide within the specified time frame prior to leukapheresis or prior to anito-cel infusion - Previous treatment with any gene therapy, chimeric antigen receptor therapy or T cell engager - Previous thymectomy within 6 months of screening - Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * Subject is pregnant or breastfeeding * Treatment with Anti-CD20 agents, calcineurin inhibitors, FcRN inhibitors, azathioprine, mycophenolate mofetil, methotrexate, or cyclophosphamide within the specified time frame prior to leukapheresis or prior to anito-cel infusion * Previous treatment with any gene therapy, chimeric antigen receptor therapy or T cell engager * Previous thymectomy within 6 months of screening * Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator

Treatments Being Tested

BIOLOGICAL

anito-cel

Anitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-Domain

DRUG

Standard Lymphodepletion regimen

Standard lymphodepletion regimen subject receive 5 days prior to CAR T infusion

Locations (13)

UCLA Medical Center
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
Stanford Hospital
Palo Alto, California, United States
University of South Florida - Carol and Frank Morsani Center of 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
Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States