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Trial Title:
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
NCT ID:
NCT06626919
Condition:
Muscular Diseases
Neuromuscular Manifestations
Autoimmune
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Myasthenia Gravis
Muscle Weakness
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Neuromuscular Manifestations
Autoimmune Diseases
Cyclophosphamide
Fludarabine
Conditions: Keywords:
ARC-311
CART
CAR-T
BCMA
Anito-cel
Generalized Myasthenia Gravis
gMG
MG
Myasthenia Gravis
non-oncology plasma cell
autoimmune
auto-antibody
chimeric antigen receptor
D-Domain chimeric antigen receptor
B-cell maturation antigen (BCMA)
anitocabtagene autoleucel
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
anito-cel
Description:
Anitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic
binding domain, called a D-Domain
Arm group label:
anito-cel
Other name:
anitocabtagene autoleucel
Other name:
CART-ddBCMA
Intervention type:
Drug
Intervention name:
Standard Lymphodepletion regimen
Description:
Standard lymphodepletion regimen subject receive 5 days prior to CAR T infusion
Arm group label:
anito-cel
Other name:
Cyclophosphamide
Other name:
Fludarabine
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.
Detailed description:
This is a Phase 1 open-label, multi-center safety and dose-escalation study of anito-cel*
in adult subjects with GMG (MGFA Grade 2 to 4a), in whom immunosuppressive therapy is
clinically indicated in the judgement of the treating neurologist. The primary objective
of this study is to assess the safety profile, including any DLT and identification of a
MTD (if applicable), to support selection of the RP2D of anito-cel when administered to
subjects with GMG.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 2025
Completion date:
April 2028
Lead sponsor:
Agency:
Arcellx, Inc.
Agency class:
Industry
Source:
Arcellx, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06626919
