What side effects are associated with this type of intervention?

Common treatments for Myasthenia Gravis include acetylcholinesterase inhibitors, immunosuppressive drugs, plasmapheresis, and intravenous immunoglobulin (IVIG). Acetylcholinesterase inhibitors can cause gastrointestinal issues, muscle cramps, and increased salivation. Immunosuppressive drugs, such as corticosteroids and azathioprine, may lead to increased infection risk, hypertension, diabetes, and osteoporosis. Plasmapheresis and IVIG can cause allergic reactions, infections, and blood clotting issues. For treatments similar to Descartes-08 CAR T-cells, which involve genetically engineered T-cells, potential side effects include cytokine release syndrome, neurotoxicity, and increased infection risk due to immune modulation.

What prior FDA approvals exist?

The FDA has approved several treatments for Myasthenia Gravis, primarily focusing on immunosuppressive therapies and acetylcholinesterase inhibitors. Notable drugs include pyridostigmine (an acetylcholinesterase inhibitor) and immunosuppressants like azathioprine, mycophenolate mofetil, and corticosteroids. Additionally, eculizumab, a monoclonal antibody that inhibits the complement system, has been approved for MG. While there are no FDA-approved treatments directly analogous to the Descartes-08 CAR T-cells, which involve genetically engineered T-cells, ongoing research and clinical trials are exploring similar advanced immunotherapies for MG.

What other types of research exist?

Promising novel alternatives to Descartes-08 CAR T-cells for Myasthenia Gravis patients include: 1) Mesenchymal stem cell (MSC) therapy, which has shown potential in modulating the immune response and reducing autoimmunity in neurological diseases. 2) Autologous hematopoietic stem cell transplantation (HSCT), which aims to reset the immune system and has been explored in autoimmune disorders. 3) Myostatin inhibitors, which are being investigated for their role in muscle strength improvement and could be beneficial for MG patients. These therapies are in various stages of clinical trials and have shown potential in modulating immune responses and improving symptoms in autoimmune and neuromuscular conditions.

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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 below

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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.

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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

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

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 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

0 / 4Eligibility criteria met

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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