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

NCT ID: NCT04146051

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2026-03-31

Brief Summary

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This is a Phase IIb study to evaluate the safety and preliminary efficacy of Descartes-08 CAR T-cells in patients with Generalized Myasthenia Gravis

Detailed Description

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Conditions

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Myasthenia Gravis, Generalized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Phase 1b Dose-Escalation

Generalized Myasthenia Gravis

Group Type EXPERIMENTAL

Descartes-08

Intervention Type DRUG

Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA

Phase IIa Expansion

Generalized Myasthenia Gravis

Group Type EXPERIMENTAL

Descartes-08

Intervention Type DRUG

Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA

Phase IIb Randomized Control Trial

Generalized Myasthenia Gravis

Group Type PLACEBO_COMPARATOR

Descartes-08

Intervention Type DRUG

Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA

Interventions

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Descartes-08

Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cartesian Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Profound Research

Carlsbad, California, United States

Site Status

University of California Irvine

Irvine, California, United States

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

SFM Clinical Research, LLC

Boca Raton, Florida, United States

Site Status

Neurology Associates, P.A.

Orlando, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

University of Augusta

Augusta, Georgia, United States

Site Status

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

Site Status

Dent Neurologic Institute

Amherst, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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United States Canada

References

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Granit V, Benatar M, Kurtoglu M, Miljkovic MD, Chahin N, Sahagian G, Feinberg MH, Slansky A, Vu T, Jewell CM, Singer MS, Kalayoglu MV, Howard JF Jr, Mozaffar T; MG-001 Study Team. Safety and clinical activity of autologous RNA chimeric antigen receptor T-cell therapy in myasthenia gravis (MG-001): a prospective, multicentre, open-label, non-randomised phase 1b/2a study. Lancet Neurol. 2023 Jul;22(7):578-590. doi: 10.1016/S1474-4422(23)00194-1.

Reference Type DERIVED
PMID: 37353278 (View on PubMed)

Meisel A. Are CAR T cells the answer to myasthenia gravis therapy? Lancet Neurol. 2023 Jul;22(7):545-546. doi: 10.1016/S1474-4422(23)00211-9. No abstract available.

Reference Type DERIVED
PMID: 37353270 (View on PubMed)

Other Identifiers

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MG-001

Identifier Type: -

Identifier Source: org_study_id

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