RecruitingPhase 1Phase 2NCT04422912

A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)

A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris


Sponsor

Cabaletta Bio

Enrollment

40 participants

Start Date

Sep 29, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

A phase 1/2, open-label, safety and dosing study of autologous CART cells (desmoglein 3 chimeric autoantibody receptor T cells \[DSG3-CAART\] or CD19-specific Chimeric Antigen Receptor T cells \[CABA-201\]) in subjects with active, pemphigus vulgaris


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1/2 study (RESET-PV) tests two CAR T-cell therapies for pemphigus vulgaris (PV) — a rare and potentially life-threatening autoimmune disease where the immune system attacks proteins that hold skin cells together, causing painful blistering on the skin and mucous membranes. Standard treatments rely on long-term immunosuppression, which carries significant risks. This trial engineers the patient's own immune cells to seek out and eliminate only the specific immune cells causing the disease. The study is currently focused on CABA-201, a CD19-targeted CAR T-cell therapy. Patients donate their own T-cells, which are genetically modified in a lab and then infused back into the body. This personalized 'living drug' is designed to reset the immune system and potentially put PV into long-term remission without lifelong immunosuppression. You may be eligible if: - You are 18 years of age or older - You have a confirmed diagnosis of pemphigus vulgaris (PV) by biopsy and positive antibody testing - Your PV is inadequately controlled by at least one standard immunosuppressive therapy - You have active PV at the time of screening You may NOT be eligible if: - You have paraneoplastic pemphigus or active malignancy (diagnosed within the last 5 years) - You have received rituximab or other anti-CD19/CD20 therapy in the last 12 months - You are taking prednisone at a dose above 0.25 mg/kg/day - You have another autoimmune disorder requiring immunosuppressive therapy - You received any investigational treatment within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDSG3-CAART

Intravenous infusions of DSG3-CAART alone at different doses and different fractionations, with or without intravenous immunoglobulin, cyclophosphamide, and/or fludarabine.

BIOLOGICALCABA-201

Single intravenous infusion of CABA-201 at escalating doses, with or without preconditioning.


Locations(13)

Stanford University, Dept. of Dermatology

Redwood City, California, United States

UC Davis, Dept. of Dermatology

Sacramento, California, United States

Yale University

New Haven, Connecticut, United States

Northwestern University

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mount Sinai - Icahn School of Medicine

New York, New York, United States

Columbia University

New York, New York, United States

University of North Carolina, Department of Dermatology

Chapel Hill, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

UT Southwestern Medical Center, Dept. of Dermatology

Dallas, Texas, United States

MD Anderson Texas Medical Center

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT04422912


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