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

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ClinicalTrials.gov Identifier: NCT04146051
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : February 10, 2021
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   
University of South Florida Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Jessica Shaw         
Principal Investigator: Tuan H. Vu, MD         
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Manisha Chopra         
Principal Investigator: James F Howard, MD         
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: February 10, 2021
Last Verified: February 2021
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
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases