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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
Summary
This trial is testing a new treatment called Descartes-08 CAR T-cells in patients with Generalized Myasthenia Gravis. The treatment involves modifying the patient's own immune cells to better attack the cells causing their muscle weakness. The goal is to see if this approach is safe and effective.
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.
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.
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 “Yes” for the criteria belowSelect...
I have been diagnosed with Generalized Myasthenia Gravis.
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I have been diagnosed with Generalized Myasthenia Gravis.
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I am 18 years old or older.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 to day 168
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 168
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of patients with MG Composite improvement of ≥5 points.
Secondary study objectives
Autoantibodies
Mg-UTP
Comparison on Descartes-08 versus placebo on QMG and MG ADL
+1 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Myasthenia Gravis (MG) include acetylcholinesterase inhibitors, immunosuppressive drugs, plasmapheresis, and intravenous immunoglobulin (IVIG). Acetylcholinesterase inhibitors, such as pyridostigmine, work by increasing the amount of acetylcholine at the neuromuscular junction, improving muscle contraction.
Immunosuppressive drugs, like corticosteroids and azathioprine, reduce the immune system's attack on acetylcholine receptors. Plasmapheresis and IVIG temporarily remove or neutralize antibodies attacking the neuromuscular junction.
Emerging treatments, such as Descartes-08 CAR T-cells, involve genetically engineered T-cells targeting specific antigens to modulate the immune response, potentially offering a more targeted and sustained approach. These mechanisms are crucial for MG patients as they directly address the underlying autoimmune response, improving muscle strength and reducing symptoms.
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Advances in Immunotherapies for Gliomas.Alternative CAR Therapies: Recent Approaches in Engineering Chimeric Antigen Receptor Immune Cells to Combat Cancer.Overview of the pre-clinical and clinical studies about the use of CAR-T cell therapy of cancer combined with oncolytic viruses.
Find a Location
Who is running the clinical trial?
Cartesian TherapeuticsLead Sponsor
8 Previous Clinical Trials
167 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People who test negative for certain antibodies are allowed to participate.I have been diagnosed with Generalized Myasthenia Gravis.I have been diagnosed with Generalized Myasthenia Gravis.I am 18 years old or older.You are taking other medications that lower your immune system, but only if your doctor thinks it's necessary.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Phase IIa Expansion
- Group 2: Phase IIb Randomized Control Trial
- Group 3: Phase 1b Dose-Escalation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.