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

Cartesian Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Myasthenia Gravis, Generalized

Treatments: Drug: Descartes-08

Study type: Interventional

Funder types: Industry

Identifiers

NCT04146051

MG-001

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Phase 1b Dose-Escalation

Experimental group

Description:

Generalized Myasthenia Gravis

Treatment:

Drug: Descartes-08

Phase IIa Expansion

Experimental group

Description:

Generalized Myasthenia Gravis

Treatment:

Drug: Descartes-08

Phase IIb Randomized Control Trial

Placebo Comparator group

Description:

Generalized Myasthenia Gravis

Treatment:

Drug: Descartes-08