Actively Recruiting
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
Led by Arcellx, Inc. · Updated on 2026-02-25
30
Participants Needed
13
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating anitocabtagene autoleucel (anito-cel), a BCMA-directed CAR-T cell therapy, in adults with generalized myasthenia gravis (GMG) classified as MGFA Grade 2 to 4a. This Phase 1 open-label, multi-center study aims to assess the safety, tolerability, and preliminary efficacy of anito-cel in patients who require immunosuppressive therapy as determined by their neurologist. The study focuses on identifying dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), and selecting the recommended Phase 2 dose (RP2D) for treatment. The study includes sequential phases: screening, enrollment with leukapheresis to collect cells, pretreatment with a standard lymphodepletion chemotherapy regimen for 5 days, and a single intravenous infusion of anito-cel cells. Optional bridging therapy may be given while the CAR-T cells are prepared. Following infusion, participants will be closely monitored for safety and efficacy outcomes over time. Participants will undergo safety monitoring for at least 28 days after infusion, with safety data collected throughout the study duration of up to 24 months. Clinical effects will be evaluated using measures including the Myasthenia Gravis Activities of Daily Living (MG ADL) score, Quantitative Myasthenia Gravis (QMG) score, and Myasthenia Gravis Composite (MGC) scale. Additionally, blood tests will monitor autoantibody levels and pharmacokinetics of the therapy. This comprehensive follow-up ensures careful assessment of treatment impact and participant health.
CONDITIONS
Brief Title
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo enrollment and leukapheresis to collect cells for modification.
1 visit (in-person)
Duration - 5 days
Participants receive a standard lymphodepletion regimen for 5 days prior to CAR T-cell infusion.
Daily visits or administration for 5 days
Duration - 1 day
Participants receive a single intravenous infusion of anito-cel (CAR T-cell therapy).
1 visit (in-person infusion)
Duration - Up to 24 months
Participants are monitored for safety, efficacy, and long-term effects after treatment.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 13 locations
1
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of California, Irvine
Orange, California, United States, 92602
Actively Recruiting
3
Stanford Hospital
Palo Alto, California, United States, 94305
Actively Recruiting
4
University of South Florida - Carol and Frank Morsani Center of Advanced Healthcare
Tampa, Florida, United States, 33612
Actively Recruiting
5
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
6
University of Minnesota Delaware Clinical Research Unit
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
7
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
9
Ohio State University
Columbus, Ohio, United States, 43221
Actively Recruiting
10
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
11
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
12
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
13
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Clinical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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