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NCT06704269 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis
A Phase 1 study of Generalized Myasthenia Gravis, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 10
- Study locations
NCT06704269: Recruiting Phase 1 study of Generalized Myasthenia Gravis, sponsored by Novartis Pharmaceuticals.
NCT06704269 is a Phase 1 study of Generalized Myasthenia Gravis that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 15 participants, below the 131-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (89% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06704269, a Phase 1 study of Generalized Myasthenia Gravis, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a phase I/II study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with treatment-resistant generalized myasthenia gravis. YTB323 is a Biological CAR-T cell therapy.
Primary Outcome
Incidence of AE's, including Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANs), changes in Vital Signs, Laboratory parameters, ECG, and neurological status qualifying and reported as AEs.
Conditions Studied
Interventions
- GENETIC YTB323
Study Locations (10)
Other
- Novartis Investigative Site - Bordeaux
- Novartis Investigative Site - Brest
- Novartis Investigative Site - Lille
- Novartis Investigative Site - Chiba
- Novartis Investigative Site - Kyoto
- Novartis Investigative Site - London
California
- Univ Cali Irvine ALS Neuromuscular - Orange
North Carolina
- Wake Forest Univ School of Medicine - Winston-Salem
Texas
- Houston Methodist Hospital - Houston
South Yorkshire
- Novartis Investigative Site - Sheffield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-04-22 |
| Est. Completion | 2029-10-26 |
| Phase | Phase 1 |
What NCT06704269 shows while recruiting
NCT06704269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 131-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 1 intervention - of which YTB323 is the first listed.
NCT06704269 lists 10 locations in 5 states (Other, California, North Carolina).
Frequently Asked Questions
What is clinical trial NCT06704269 about?
NCT06704269 is a clinical study titled "Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis". This is a phase I/II study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with treatment-resistant generalized myasthenia gravis. YTB323 is a Biological CAR-T cell therapy.
What is the current status of trial NCT06704269?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2025-04-22. Estimated completion is 2029-10-26.
What conditions does trial NCT06704269 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis.
What interventions are being tested in trial NCT06704269?
The interventions under investigation include: YTB323 (GENETIC).
Who is sponsoring clinical trial NCT06704269?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06704269 being conducted?
This trial has 10 study locations across California, North Carolina, Texas, South Yorkshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06704269's enrollment target sits among peer trials
15 20th of 26 higher than 6 of 26 other Generalized Myasthenia Gravis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Myasthenia Gravis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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