Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myasthenia Gravis, Generalized | Drug: Descartes-08 | Phase 1 Phase 2 |
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 |

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 |
- Maximum Tolerated Dose [ Time Frame: 28 days ]Maximum Tolerated Dose (MTD)
- Myasthenia Gravis -Activities of Daily Living Score [ Time Frame: Day 0 to Day 168 ]Change in Myasthenia Gravis of Daily Living Score

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

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
Contact: Study Trial Central Mailbox | 302-648-6497 | trials@cartesiantx.com |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Descartes-08 CART CAR-T |
Autoimmune Auto-antibody Auto antibody |
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 |