What side effects are associated with this type of intervention?

Common treatments for dermatomyositis include immunosuppressive agents such as rituximab, mycophenolate mofetil, and calcineurin inhibitors like tacrolimus and cyclosporine. Rituximab, which targets CD20-positive B cells, can cause infusion reactions, infections, and hypogammaglobulinemia. Mycophenolate mofetil may lead to gastrointestinal issues and increased risk of infections. Calcineurin inhibitors, including tacrolimus and cyclosporine, can cause nephrotoxicity, hypertension, and increased susceptibility to infections. These treatments share similarities with CAR T Therapy in targeting specific immune cells, and their side effects primarily involve immune suppression and related complications.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for CAR T therapy or similar treatments targeting CD19-expressing B cells in dermatomyositis within the provided context. However, the context does discuss the use of rituximab, an anti-CD20 monoclonal antibody, which has shown potential effectiveness in treating refractory dermatomyositis and polymyositis. Additionally, other immunosuppressive and immunomodulatory agents are commonly used in the management of dermatomyositis.

What other types of research exist?

Promising novel alternatives to CAR T therapy for Dermatomyositis patients in 2024 include Bi-specific T-cell engagers (BiTEs), CELMoDs targeting cereblon, and sirolimus. These therapies offer different mechanisms of action and have shown potential in treating autoimmune and inflammatory conditions.

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CAR T-cell Therapy

CAR T Therapy for Dermatomyositis

Phase 1

Waitlist Available

Led By David Fiorentino, MD, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Summary

This trial tests a new therapy in adults with dermatomyositis. The therapy modifies their white blood cells to target and destroy harmful B cells, aiming to reset their immune system and reduce disease symptoms. This new treatment shows promising results in similar conditions.

Who is the study for?

This trial is for adults with dermatomyositis, an autoimmune disease. Participants must have their own T cells modified to target B cells that may be causing the disease. It's not specified who can't join, but typically those with other serious health issues or immune deficiencies might be excluded.

What is being tested?

The study tests KYV-101 Anti-CD19 CAR T Therapy in adults with dermatomyositis. Patients' T cells are engineered to destroy B cells by recognizing CD19 protein, potentially resetting the immune system and alleviating the disease.

What are the potential side effects?

Potential side effects include reactions related to immune system changes such as flu-like symptoms, fatigue, fever, and possibly more severe complications due to a significant alteration of the immune response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants experiencing adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Active Intervention with CAR TExperimental Treatment1 Intervention

All participants in the trial will receive an infusion of autologous, genetically modified CAR T cells specific for the CD19 antigen

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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

Common treatments for Dermatomyositis include glucocorticoids, immunosuppressive agents like methotrexate and azathioprine, and biologics such as rituximab. Glucocorticoids reduce inflammation by suppressing the immune response. Immunosuppressive agents inhibit the proliferation of immune cells, thereby reducing the autoimmune attack on muscle tissues. Rituximab, a monoclonal antibody, targets CD20 on B cells, leading to their depletion. This is similar to CAR T Therapy, which modifies cytotoxic T lymphocytes to target and eliminate CD19-expressing B cells, aiming to reset the immune system by removing the B cells responsible for autoantibody production. Understanding these mechanisms is crucial for Dermatomyositis patients as it helps in selecting the most appropriate treatment strategy to manage their condition effectively.

Neurological adverse events of immune checkpoint blockade: from pathophysiology to treatment.A case of successful pembrolizumab rechallenge in a patient with non-small-cell lung cancer and grade 3 dermatomyositis.The effects of FK506 on refractory inflammatory myopathies.

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,448 Previous Clinical Trials

17,492,373 Total Patients Enrolled

1 Trials studying Dermatomyositis

5 Patients Enrolled for Dermatomyositis

David Fiorentino, MD, PhDPrincipal InvestigatorStanford University

Everett Meyer, MDPrincipal InvestigatorStanford University

2 Previous Clinical Trials

26 Total Patients Enrolled

~14 spots leftby Apr 2027

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