A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
NCT06626919 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-02-25
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.
Conditions
- Muscular Diseases
- Neuromuscular Manifestations
- Autoimmune
- Autoimmune Diseases
- Autoimmune Diseases of the Nervous System
- Myasthenia Gravis
- Muscle Weakness
Interventions
- BIOLOGICAL
-
anito-cel
Anitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-Domain
- DRUG
-
Standard Lymphodepletion regimen
Standard lymphodepletion regimen subject receive 5 days prior to CAR T infusion
Sponsors & Collaborators
-
Arcellx, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-30
- Primary Completion
- 2027-03-31
- Completion
- 2028-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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