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anito-cel (anitocabtagene autoleucel)

Phase 1

Muscular Diseases | Cell Therapies | Immunology |Arcellx, Inc.|Trials Updated: Oct 22, 2026

anito-cel (anitocabtagene autoleucel) target and mechanism

Target class-Cel (Cell Tx)
ModalityCell Therapies

Also known as anito-cel

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

anito-cel (anitocabtagene autoleucel) clinical trials

anito-cel (anitocabtagene autoleucel) · 1 trial · 7 indications

Phase 1 1
NCT06626919Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related DiseasesMuscular Diseases
RECRUITING30 Analytics
PHASE1RECRUITING
Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases
Muscular DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
First dose date up to 24 months
Percentage of Participants Experiencing Dose-Limiting Toxicities (DLT)
Up to 28 days following anito-cel infusion
Maximum Tolerated Dose (MTD) of Anito-cel
First dose up to 30 days (Up to 24 months)
Percentage of Participants With Laboratory Abnormalities
First dose date up to 24 months
Recommended Phase 2 Dose (RP2D) of Anito-cel
Up to 24 months

Secondary Endpoints

Proportion of Participants Achieving a ≥2-Point Change in the Myasthenia Gravis Activities of Daily Living (MG ADL) Score From Baseline at any Timepoint After Treatment.
Baseline, Up to 24 months
Proportion of Participants Achieving a ≥3-Point Change in the Quantitative Myasthenia Gravis (QMG) Score From Baseline at any Timepoint After Treatment.
Baseline, Up to 24 months
Proportion of Participants Achieving a ≥3-Point Change in the Myasthenia Gravis Composite (MGC) Score From Baseline at any Timepoint After Treatment.
Baseline, Up to 24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Anito-cel (Dose Escalation)EXPERIMENTALParticipant will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of anito-cel. Anito-cel will be given at one of several possible doses in dose escalation until the optimal dose is identified.
Anito-cel (Dose Expansion)EXPERIMENTALParticipant will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of anito-cel. Anito-cel will be given at the optimal dose identified in dose escalation.

Interventions

NameTypeDescription
anito-celBIOLOGICALAnitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-Domain
CyclophosphamideDRUGAdministered intravenously
FludarabineDRUGAdministered intravenously
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Key Inclusion Criteria: * Individuals must be 18 years of age or older * Must have Myasthenia Gravis Foundation of America (MGFA) clinical classification Grades 2-4A at time of screening * Participant must have clinically active disease and requiring ongoing therapy for Generalized Myasthenia Gravi...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMOct 22, 2026NCT06626919primaryCompletionDate: changed
MEDIUMOct 22, 2026NCT06626919primaryCompletionDate: changed

Frequently asked questions about anito-cel (anitocabtagene autoleucel)

What is anitocabtagene autoleucel (anito-cel)?

Anitocabtagene autoleucel, also known as anito-cel, is an investigational CAR-T cell therapy developed by Arcellx, Inc. It is being studied in non-oncology plasma cell-related diseases, including muscular and neuromuscular conditions such as myasthenia gravis and muscle weakness. It is in Phase 1 clinical development.

What is anito-cel used for?

Anito-cel is being studied for non-oncology plasma cell-related diseases. The Phase 1 trial enrolls adults with conditions that include muscular diseases, neuromuscular manifestations, autoimmune diseases, autoimmune diseases of the nervous system, myasthenia gravis, and muscle weakness. It is investigational and has not been established as a treatment.

Who is developing anito-cel?

Anito-cel is being developed by Arcellx, Inc., which trades under the ticker ACLX. The company is sponsoring the Phase 1 study of anitocabtagene autoleucel in non-oncology plasma cell-related diseases.

What phase is anito-cel in?

Anito-cel is in Phase 1 clinical development. Anitocabtagene autoleucel is investigational and is being evaluated in a single recruiting Phase 1 study in non-oncology plasma cell-related diseases. It has not completed a pivotal trial.

What clinical trial is anito-cel in?

Anito-cel is being studied in trial NCT06626919, a Phase 1 study of anitocabtagene autoleucel in participants with non-oncology plasma cell-related diseases. The trial is recruiting in the United States, is controlled, is not randomized or double-blind, and plans to enroll about 30 participants aged 18 years and older.

Is anitocabtagene autoleucel the same as anito-cel?

Yes, anito-cel is the short name for anitocabtagene autoleucel. Both names refer to the same investigational CAR-T cell therapy developed by Arcellx, Inc. (ACLX) and being studied in a Phase 1 trial in non-oncology plasma cell-related diseases.