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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Kansas Medical Center Research Institute
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
Cartesian Therapeutics

Study Contact

Study Trial Central Mailbox
302-648-6497
trials@cartesiantx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.