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 : May 19, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myasthenia Gravis, Generalized | Drug: Descartes-08 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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, 2023 |
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 |
Placebo Comparator: Phase IIb Randomized Control Trial
Generalized Myasthenia Gravis
|
Drug: Descartes-08
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA |
- Myasthenia Gravis -Activities of Daily Living Score [ Time Frame: Day 0 to Day 85 ]In Part 3, the primary objective is to compare the effect of Descartes-08 versus placebo, as measured by the change in MG ADL score from baseline to Week 12. In Part 1, up to three ascending doses of Descartes-08 will be administered to each of 3 to 6 patients; the patients will be staggered at least 21 days apart and will complete a safety review between each dose. In Part 2, patients will receive up to 6 doses in three different schedules depending on the arm they were enrolled into and will be monitored for up to 1 year to assess the safety and tolerability of a repeated dosing schedule.
- Comparison on Descartes-08 versus placebo on QMG, MG QoL 15R, MG Composite, MG PIS [ Time Frame: Day 0 to Day 85 ]Compare the effect of Descartes-08 versus placebo on QMG, MG QoL 15R, MG Composite, and MG PIS (change from baseline to Week 12) for all randomized patients (Part 3 only).
- Comparison on Descartes-08 versus placebo on MG assessments in crossover patients [ Time Frame: Day 0 to Day 85 ]Compare the effect of Descartes-08 versus placebo on MG ADL, QMG, MG QoL 15R, MG Composite, and MG PIS (change from baseline to Week 12) in patients who cross over from placebo to Descartes-08 (Part 3 only).
- Change in titer of myasthenia specific autoantibody titers [ Time Frame: Day 0 to Day 168 ]Determine the change from baseline over a period of 24 weeks in the titer of myasthenia specific autoantibody titers, e.g. nicotinic acetylcholine receptor autoantibody (anti-nAChR) or muscle-specific tyrosine kinase autoantibody (anti- MusK or anti-Low-Density-Lipoprotein-Related-Protein4 (anti-LRP4) or anti-AChR cluster antibody and the 4 Immunoglobulin types (IgG, IgM, IgA, IgE) following single or multiple infusions of Descartes-08 in MG auto-antibody seropositive patients (Parts 1 and 2 only)
- Effect of single or multiple infusions of Descartes-08 on patients by standard clinical assessment scales [ Time Frame: Day 0 to Day 168 ]Quantify the clinical effect of single or multiple infusions of Descartes-08 on patients by standard clinical assessment scales (MG ADL, QMG, MG QoL 15R, MG PIS, MG Composite) over a period of 24 weeks in MG auto-antibody seropositive and seronegative patients together and separately (all parts).

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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.
- Seronegative Patients are included
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, California | |
The Research Center of Southern California | Recruiting |
Carlsbad, California, United States, 92011 | |
Principal Investigator: Gregory Sahagian, MD | |
University of California Irvine | Recruiting |
Irvine, California, United States, 92697 | |
Principal Investigator: Tahseen Mozaffar, MD | |
United States, Colorado | |
University of Colorado Anschutz Medical Campus | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Brianna Blume | |
Principal Investigator: Thomas Ragole, M.D. | |
United States, Florida | |
SFM Clinical Research, LLC | Recruiting |
Boca Raton, Florida, United States, 33487 | |
Principal Investigator: Marc Feinberg, MD | |
Neurology Associates, P.A. | Recruiting |
Orlando, Florida, United States, 32751 | |
Principal Investigator: Adam Slansky, MD | |
University of South Florida | Recruiting |
Tampa, Florida, United States, 33612 | |
Principal Investigator: Tuan H. Vu, MD | |
United States, Georgia | |
University of Augusta | Recruiting |
Augusta, Georgia, United States, 30912 | |
Principal Investigator: Michael Rivner, MD | |
United States, Kansas | |
University of Kansas Medical Center Research Institute | Recruiting |
Kansas City, Kansas, United States, 66160 | |
Contact: Ali Ciersdorff | |
Contact: Andrew Heim | |
Principal Investigator: Mamatha Pasnoor, M.D. | |
United States, New York | |
Dent Neurologic Institute | Recruiting |
Amherst, New York, United States, 14226 | |
Principal Investigator: Bennett Myers, MD | |
United States, North Carolina | |
University of North Carolina | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Principal Investigator: James F Howard, MD | |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Principal Investigator: Nizar Chahin, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Kelsey Moulton | |
Contact: Sara-Claude Michon, Ph.D. | |
Principal Investigator: Chafic Karam, M.D. | |
Alleghany Health Network | Recruiting |
Pittsburgh, Pennsylvania, United States, 15212 | |
Contact: Dom Contestabile | |
Principal Investigator: George Small, M.D. | |
United States, Virginia | |
Virginia Commonwealth University | Recruiting |
Richmond, Virginia, United States, 23219 | |
Contact: Melissa Hayes | |
Principal Investigator: Kelly Gwathmey, M.D. | |
Canada, Alberta | |
University of Alberta | Recruiting |
Edmonton, Alberta, Canada, T6G2C8 | |
Contact: Faraz Hussain, Ph.D. | |
Principal Investigator: Zaeem Siddiqi, M.D. |
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: | May 19, 2023 |
Last Verified: | May 2023 |
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 |
chimeric antigen receptor T cells MG gMG Myasthenia Gravis Generalized Myasthenia gravis |
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 |