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

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

  • Myasthenia Gravis, Generalized

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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

More Details

Status
Active, not recruiting
Sponsor
Cartesian Therapeutics

Study Contact