A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
NCT ID: NCT06626919
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-04-30
2028-04-30
Brief Summary
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Detailed Description
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The study will have the following sequential phases: screening, enrollment (leukapheresis), pretreatment with lymphodepletion (LD) chemotherapy, treatment with anito-cel and follow-up. Optional bridging therapy is allowed at investigator discretion while anito-cel is being manufactured.
Following a single infusion of anito-cel both safety and efficacy data will be assessed. The DLTs will be assessed in the first 28 days following anito-cel administration, and safety data will be collected throughout the study.
\*Anitocabtagene autoleucel (anito-cel) drug product consists of autologous T cells that have been genetically modified ex vivo to express a D-domain Chimeric Antigen Receptor (CAR), followed by a cluster of differentiation 8 (CD8) hinge and transmembrane region that is fused to the intracellular signaling domains for 4-1BB and CD3ΞΎ, that specifically recognizes B-cell maturation antigen (BCMA). The active substance of anitocabtagene autoleucel is CAR+ CD3+ T cells that have undergone ex vivo T-cell activation, gene transfer by replication-deficient lentiviral vector, and expansion.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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anito-cel
Single dose of anito-cel cells infused intravenously
anito-cel
Anitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-Domain
Standard Lymphodepletion regimen
Standard lymphodepletion regimen subject receive 5 days prior to CAR T infusion
Interventions
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anito-cel
Anitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-Domain
Standard Lymphodepletion regimen
Standard lymphodepletion regimen subject receive 5 days prior to CAR T infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Arcellx, Inc.
INDUSTRY
Responsible Party
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Locations
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UCLA Medical Center
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
Stanford Hospital
Palo Alto, California, United States
Karmanos Cancer Institute
Detroit, Michigan, 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
Houston Methodist Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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ARC-311
Identifier Type: -
Identifier Source: org_study_id
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