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CAR T-cell Therapy

Descartes-08 for Myasthenia Gravis

Phase 2
Recruiting
Research Sponsored by Cartesian Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have Generalized Myasthenia Gravis at the time of screening
Patient must have Generalized Myasthenia Gravis at the time of screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 168
Awards & highlights

Study Summary

This trial is testing a new treatment for Myasthenia Gravis, a disease that causes muscle weakness.

Who is the study for?
This trial is for adults over 18 with Generalized Myasthenia Gravis (MG), a condition causing muscle weakness. Participants must be taking immunosuppressive drugs, as deemed necessary by the study's doctor. It's not for those with major unmanaged chronic illnesses or pregnant/lactating individuals.Check my eligibility
What is being tested?
The trial is testing Descartes-08 CAR-T cells to see if they are safe and can help improve symptoms in patients with MG. This Phase IIb study will give participants this new type of cell therapy that's designed to target and modify their immune system.See study design
What are the potential side effects?
While specific side effects of Descartes-08 aren't listed, similar therapies may cause flu-like symptoms, fatigue, headache, fever, and potential immune system reactions. The exact side effects will be monitored closely throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
Select...
I have been diagnosed with Generalized Myasthenia Gravis.
Select...
I have been diagnosed with Generalized Myasthenia Gravis.
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 168
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 168 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Myasthenia Gravis -Activities of Daily Living Score
Secondary outcome measures
Autoantibodies
Mg-UTP
Comparison on Descartes-08 versus placebo on QMG, MG QoL 15R, MG Composite, MG PIS
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase IIa ExpansionExperimental Treatment1 Intervention
Generalized Myasthenia Gravis
Group II: Phase 1b Dose-EscalationExperimental Treatment1 Intervention
Generalized Myasthenia Gravis
Group III: Phase IIb Randomized Control TrialPlacebo Group1 Intervention
Generalized Myasthenia Gravis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Descartes-08
2018
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Cartesian TherapeuticsLead Sponsor
8 Previous Clinical Trials
218 Total Patients Enrolled

Media Library

Descartes-08 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04146051 β€” Phase 2
Myasthenia Gravis Research Study Groups: Phase IIb Randomized Control Trial, Phase IIa Expansion, Phase 1b Dose-Escalation
Myasthenia Gravis Clinical Trial 2023: Descartes-08 Highlights & Side Effects. Trial Name: NCT04146051 β€” Phase 2
Descartes-08 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04146051 β€” Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there restrictions on the number of participants who can join this clinical research?

"This research endeavour requires 30 participants who meet the pre-defined qualifications. Eligible patients can partake in this experiment at University of Miami, situated in Florida or University of Augusta found in Georgia."

Answered by AI

Is enrollment currently open for this experiment?

"According to the clinicaltrials.gov website, this medical trial remains open and is now accepting applicants. The details of the study were first posted on December 4th 2019 and have since been updated as recently as November 18th 2022."

Answered by AI

What is the purpose of this clinical experiment?

"This clinical trial, with an assessment period of 28 days, endeavors to assess the impact of Myasthenia gravis -Activities of Daily Living Score. Secondary objectives include analyzing Descartes-08's efficacy versus placebo on QMG, MG QoL 15R, MG Composite and MG PIS (change from baseline to Week 12) in all randomized patients; comparing crossover patients who transitioned from placebo to Descartes-08 on corresponding assessments over a similar time frame; and evaluating single or multiple infusions of Descartes-08 by standard clinical scales for both autoantibody seropositive and negative subjects over"

Answered by AI

What deleterious impacts could Descartes-08 have on patient health?

"Descartes-08 is deemed moderately safe by the evaluation team at Power because this Phase 2 trial has only showcased data of its safety, not efficacy. Thus it was awarded a score of two."

Answered by AI

What is the geographic range of this trial's implementation?

"This trial is still enrolling participants across 13 sites, including Miami, Augusta and Pittsburgh. It's prudent to choose the closest location possible in order to minimize travel demands if you decide to take part."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~6 spots leftby Mar 2025