ACTIVE_NOT_RECRUITING

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

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Conditions

Myasthenia Gravis, GeneralizedDescartes-08CARTCAR-TAutoimmuneAuto-antibodyAuto antibodychimeric antigen receptorT cellsMGgMGMyasthenia GravisGeneralized Myasthenia gravis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Autologous T-Cells Expressing A Chimeric Antigen Receptor Directed To B-Cell Maturation Antigen (BCMA) In Patients With Generalized Myasthenia Gravis (MG)

Quick Facts

Study Start:2019-12-04
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04146051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must be at least 18 years of age.
  2. * Patient must have Generalized Myasthenia Gravis at the time of screening.
  3. * Concomitant immunosuppressive drugs must be deemed necessary by the investigator.
  4. * Seronegative Patients are included
  1. * 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.
  2. * Patient is pregnant or lactating.

Contacts and Locations

Study Locations (Sites)

Profound Research
Carlsbad, California, 92011
United States
University of California Irvine
Irvine, California, 92697
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
SFM Clinical Research, LLC
Boca Raton, Florida, 33487
United States
Neurology Associates, P.A.
Orlando, Florida, 32751
United States
University of South Florida
Tampa, Florida, 33612
United States
University of Augusta
Augusta, Georgia, 30912
United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
United States
Dent Neurologic Institute
Amherst, New York, 14226
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
United States
Virginia Commonwealth University
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: Cartesian Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-04
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2019-12-04
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Descartes-08
  • CART
  • CAR-T
  • Autoimmune
  • Auto-antibody
  • Auto antibody
  • chimeric antigen receptor
  • T cells
  • MG
  • gMG
  • Myasthenia Gravis
  • Generalized Myasthenia gravis

Additional Relevant MeSH Terms

  • Myasthenia Gravis, Generalized