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

Sponsor

Cartesian Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04146051

Collaborator

(none)

Enrollment

Locations

Arms

47.9

Anticipated Duration (Months)

1.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myasthenia Gravis, Generalized	Drug: Descartes-08	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

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 :

Dec 4, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Maximum Tolerated Dose [28 days]
Maximum Tolerated Dose (MTD)

Secondary Outcome Measures

Myasthenia Gravis -Activities of Daily Living Score [Day 0 to Day 168]
Change in Myasthenia Gravis of Daily Living Score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barrow Neurological Institute	Phoenix	Arizona	United States	85013
2	The Research Center of Southern California	Carlsbad	California	United States	92011
3	University of California Irvine	Irvine	California	United States	92697
4	University of Colorado-Denver	Aurora	Colorado	United States	80045
5	SFM Clinical Research, LLC	Boca Raton	Florida	United States	33487
6	Neurology Associates, P.A.	Orlando	Florida	United States	32751
7	University of South Florida	Tampa	Florida	United States	33612
8	University of Augusta	Augusta	Georgia	United States	30912
9	University of North Carolina	Chapel Hill	North Carolina	United States	27599
10	Oregon Health & Science University	Portland	Oregon	United States	97239
11	Allegheny Health Network	Pittsburgh	Pennsylvania	United States	15212
12	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232-2551