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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146051
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Study Description
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Brief Summary:
This is a Phase Ib/IIa study to evaluate the safety and preliminary efficacy of Descartes-08 CAR T-cells in patients with Generalized Myasthenia Gravis

Condition or disease Intervention/treatment Phase
Myasthenia Gravis, Generalized Drug: Descartes-08 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous T-Cells Expressing A Chimeric Antigen Receptor Directed To B-Cell Maturation Antigen (BCMA) In Patients With Generalized Myasthenia Gravis (MG)
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1b Dose-Escalation
Generalized Myasthenia Gravis
 Drug: Descartes-08
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
Experimental: Phase IIa Expansion
Generalized Myasthenia Gravis
 Drug: Descartes-08
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 28 days ]
    Maximum Tolerated Dose (MTD)


Secondary Outcome Measures :
  1. Myasthenia Gravis -Activities of Daily Living Score [ Time Frame: Day 0 to Day 168 ]
    Change in Myasthenia Gravis of Daily Living Score


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146051


Contacts
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Contact: Study Trial Central Mailbox 302-648-6497 trials@cartesiantx.com

Locations
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United States, California
University of California Irvine Recruiting
Irvine, California, United States, 92697
Contact: Investigator         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Volkan Granit       vgranit@med.miami.edu   
Sponsors and Collaborators
Cartesian Therapeutics
More Information
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Responsible Party: Cartesian Therapeutics
ClinicalTrials.gov Identifier: NCT04146051    
Other Study ID Numbers: MG-001
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cartesian Therapeutics:
Descartes-08
CART
CAR-T
 Autoimmune
Auto-antibody
Auto antibody
Additional relevant MeSH terms:
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Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
 Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs