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NCT04146051 · ClinicalTrials.gov registry record · Phase 2
Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)
A Phase 2 study of Myasthenia Gravis, Generalized, sponsored by Cartesian Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 15
- Study locations
NCT04146051: Active Phase 2 study of Myasthenia Gravis, Generalized, sponsored by Cartesian Therapeutics.
NCT04146051 is a Phase 2 study of Myasthenia Gravis, Generalized that is active but no longer recruiting, run by Cartesian Therapeutics. The registered enrollment target is 30 participants, below the 1,328-participant average among 3 other Myasthenia Gravis, Generalized trials with a reported enrollment target (98% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04146051, a Phase 2 study of Myasthenia Gravis, Generalized, is active but no longer recruiting, sponsored by Cartesian Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is a Phase IIb study to evaluate the safety and preliminary efficacy of Descartes-08 CAR T-cells in patients with Generalized Myasthenia Gravis
Primary Outcome
In Part 3, the primary objective is to compare the effect of Descartes-08 versus placebo, as measured by the change in MGC score from baseline to Week 12. In Part 1, up to three ascending doses of Descartes-08 will be administered to each of 3 to 6 patients; the patients will be staggered at least 21 days apart and will complete a safety review between each dose. In Part 2, patients will receive up to 6 doses in three different schedules depending on the arm they were enrolled into and will be m
Conditions Studied
Interventions
- DRUG Descartes-08
Study Locations (15)
Florida
- SFM Clinical Research, LLC - Boca Raton
- Neurology Associates, P.A. - Orlando
- University of South Florida - Tampa
California
- Profound Research - Carlsbad
- University of California Irvine - Irvine
Pennsylvania
- University of Pennsylvania - Philadelphia
- Allegheny Health Network - Pittsburgh
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Georgia
- University of Augusta - Augusta
Kansas
- University of Kansas Medical Center Research Institute - Kansas City
New York
- Dent Neurologic Institute - Amherst
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-12-04 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 2 |
What the registry record for NCT04146051 still lists
NCT04146051 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 1,328-participant average among 3 other Myasthenia Gravis, Generalized trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Myasthenia Gravis, Generalized appearing as the primary indexed condition, and to 1 intervention - of which Descartes-08 is the first listed.
NCT04146051 lists 15 locations in 11 states (Florida, California, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT04146051 about?
NCT04146051 is a clinical study titled "Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)". This is a Phase IIb study to evaluate the safety and preliminary efficacy of Descartes-08 CAR T-cells in patients with Generalized Myasthenia Gravis
What is the current status of trial NCT04146051?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-12-04. Estimated completion is 2026-03-31.
What conditions does trial NCT04146051 study?
This clinical trial studies the following conditions: Myasthenia Gravis, Generalized.
What interventions are being tested in trial NCT04146051?
The interventions under investigation include: Descartes-08 (DRUG).
Who is sponsoring clinical trial NCT04146051?
This trial is sponsored by Cartesian Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04146051 being conducted?
This trial has 15 study locations across California, Colorado, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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