A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases

Part of paid clinical trials in Los Angeles, California.

Sponsor
Arcellx, Inc.
Study ID
NCT06626919
Phase
PHASE1
Status
Recruiting
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Conditions

  • Autoimmune
  • Autoimmune Diseases
  • Autoimmune Diseases of the Nervous System
  • Muscle Weakness
  • Muscular Diseases
  • Myasthenia Gravis
  • Neuromuscular Manifestations

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • anito-cel — BIOLOGICAL
    Anitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-Domain
  • Standard Lymphodepletion regimen — DRUG
    Standard lymphodepletion regimen subject receive 5 days prior to CAR T infusion

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: anito-cel
    Single dose of anito-cel cells infused intravenously

Primary Outcome Measure

Assess safety profile, including any DLT and MTD (if applicable) [ Time Frame: 24 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterLos AngelesCalifornia90095-
University of California, IrvineOrangeCalifornia92602-
Stanford HospitalPalo AltoCalifornia94305-
University of South Florida - Carol and Frank Morsani Center of Advanced HealthcareTampaFlorida33612-
Karmanos Cancer InstituteDetroitMichigan48201-
University of Minnesota Delaware Clinical Research UnitMinneapolisMinnesota55414-
Mayo ClinicRochesterMinnesota55905-
Columbia University Irving Medical CenterNew YorkNew York10032-
Ohio State UniversityColumbusOhio43221-
Oregon Health & Science University (OHSU)PortlandOregon97239-
Temple University HospitalPhiladelphiaPennsylvania19140-
UT Southwestern Medical CenterDallasTexas75390-
Houston Methodist HospitalHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
UCLA Medical Center· Los Angeles, CAUniversity of California, Irvine· Orange, CAStanford Hospital· Palo Alto, CAUniversity of South Florida - Carol and Frank Morsani Center of Advanced Healthcare· Tampa, FLKarmanos Cancer Institute· Detroit, MIUniversity of Minnesota Delaware Clinical Research Unit· Minneapolis, MN

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