Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Study Trial Central Mailbox 302-648-6497 trials@cartesiantx.com

Locations
Layout table for location information
United States, Arizona
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Nicole Turcotte    602-406-4775    nicole.turcotte@dignityhealth.org   
Principal Investigator: Shafeeq Ladha, MD         
United States, California
The Research Center of Southern California Recruiting
Carlsbad, California, United States, 92011
Contact: April Tenorio    760-732-0557 ext 2135    tenorioa@neurocenter.com   
Principal Investigator: Gregory Sahagian, MD         
University of California Irvine Recruiting
Irvine, California, United States, 92697
Contact: Investigator         
United States, Florida
SFM Clinical Research, LLC Recruiting
Boca Raton, Florida, United States, 33487
Contact: Gabrielle DeMaria    561-939-0333    gabrielle@sfmresearch.com   
Contact: Yousra Erritouni    5614194303    yousra@sfmresearch.com   
Principal Investigator: Marc Feinberg, MD         
Neurology Associates, P.A. Recruiting
Orlando, Florida, United States, 32751
Contact: Kelly Holley    407-646-5996    neurologyassoc@hotmail.com   
Principal Investigator: Adam Slansky, MD         
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 Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Manisha Chopra         
Principal Investigator: James F Howard, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Diana Dimitrova    503-494-0744    dimitrov@ohsu.edu   
Principal Investigator: Nizar Chahin, MD         
Sponsors and Collaborators
Cartesian Therapeutics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases