Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)

NCT04146051 · tracked via the Priya Life Science Canada tracker

Sponsor

Cartesian Therapeutics

Phase

Phase 2

Started

2019-12-04

Last updated

2026-08-14

Condition(s) studied

Myasthenia Gravis, Generalized

Investigational drug(s) / intervention(s)

Descartes-08 →

Descartes-08: Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient must be at least 18 years of age. * Patient must have Generalized Myasthenia Gravis at the time of screening. * Concomitant immunosuppressive drugs must be deemed necessary by the investigator. * Seronegative Patients are included Exclusion Criteria: * Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient. * Patient is pregnant or lactating.

Primary outcome measure(s)

Proportion of patients with MG Composite improvement of ≥5 points. — Day 0 to Day 85
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 monitored for up to 1 year to assess the safety and tolerability of a repeated dosing schedule.

Trial sites (15)

Facility	City	Region
Profound Research	Carlsbad	California
University of California Irvine	Irvine	California
University of Colorado Anschutz Medical Campus	Aurora	Colorado
SFM Clinical Research, LLC	Boca Raton	Florida
Neurology Associates, P.A.	Orlando	Florida
University of South Florida	Tampa	Florida
University of Augusta	Augusta	Georgia
University of Kansas Medical Center Research Institute	Kansas City	Kansas
Dent Neurologic Institute	Amherst	New York
University of North Carolina	Chapel Hill	North Carolina
Oregon Health & Science University	Portland	Oregon
University of Pennsylvania	Philadelphia	Pennsylvania
Allegheny Health Network	Pittsburgh	Pennsylvania
Virginia Commonwealth University	Richmond	Virginia
University of Alberta	Edmonton	Alberta

More Cartesian Therapeutics trials in Canada

Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis Active, not recruiting

Other trials for the same condition

A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis Active, not recruiting

A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04146051 on ClinicalTrials.gov ↗ ← All trials in Canada