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New treatment option for Muscular Diseases
Official title A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
ClinicalTrials.gov ID: NCT06626919
What this study is testing
What is anito-cel?
anito-cel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for muscular diseases.
Also referred to as anitocabtagene autoleucel, CART-ddBCMA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Subject is pregnant or breastfeeding
- Treatment with Anti-CD20 agents, calcineurin inhibitors, FcRN inhibitors, azathioprine, mycophenolate mofetil, methotrexate, or cyclophosphamide...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Tampa, Florida, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States; Tampa, Florida, United States; Detroit, Michigan, United States; Minneapolis, Minnesota, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.