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NCT06626919 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
A Phase 1 study of Myasthenia Gravis and Autoimmune Diseases, sponsored by Arcellx.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 13
- Study locations
NCT06626919: Recruiting Phase 1 study of Myasthenia Gravis and Autoimmune Diseases, sponsored by Arcellx.
NCT06626919 is a Phase 1 study of Myasthenia Gravis and Autoimmune Diseases that is actively recruiting participants, run by Arcellx. The registered enrollment target is 30 participants, below the 190-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (84% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06626919, a Phase 1 study of Myasthenia Gravis and Autoimmune Diseases, is actively recruiting participants, sponsored by Arcellx.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
Type, incidence, and severity of treatment-emergent adverse events (TEAEs), including DLT(s) and laboratory abnormalities
Conditions Studied
Interventions
- BIOLOGICAL anito-cel
- DRUG Standard Lymphodepletion regimen
Study Locations (13)
California
- UCLA Medical Center - Los Angeles
- University of California, Irvine - Orange
- Stanford Hospital - Palo Alto
Minnesota
- University of Minnesota Delaware Clinical Research Unit - Minneapolis
- Mayo Clinic - Rochester
Texas
- UT Southwestern Medical Center - Dallas
- Houston Methodist Hospital - Houston
Florida
- University of South Florida - Carol and Frank Morsani Center of Advanced Healthcare - Tampa
Michigan
- Karmanos Cancer Institute - Detroit
New York
- Columbia University Irving Medical Center - New York
Ohio
- Ohio State University - Columbus
Oregon
- Oregon Health & Science University (OHSU) - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-04-30 |
| Est. Completion | 2028-04 |
| Phase | Phase 1 |
What NCT06626919 shows while recruiting
NCT06626919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 190-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (84% lower).
The record links to 7 conditions, with Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions - of which anito-cel is the first listed.
NCT06626919 lists 13 locations in 9 states (California, Minnesota, Texas).
Frequently Asked Questions
What is clinical trial NCT06626919 about?
NCT06626919 is a clinical study titled "A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases". 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.
What is the current status of trial NCT06626919?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-04-30. Estimated completion is 2028-04.
What conditions does trial NCT06626919 study?
This clinical trial studies the following conditions: Myasthenia Gravis, Autoimmune Diseases, Muscle Weakness, Neuromuscular Manifestations, Muscular Diseases.
What interventions are being tested in trial NCT06626919?
The interventions under investigation include: anito-cel (BIOLOGICAL), Standard Lymphodepletion regimen (DRUG).
Who is sponsoring clinical trial NCT06626919?
This trial is sponsored by Arcellx, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06626919 being conducted?
This trial has 13 study locations across California, Florida, Michigan, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06626919's enrollment target sits among peer trials
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