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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
No Placebo-Only Group

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 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,467 Previous Clinical Trials
17,496,081 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