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โ† Trials
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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)

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllCabaletta Bio
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria for DSG3-CAART: Closed to enrollment * Confirmed diagnosis of mPV by prior or screening biopsy and prior positive anti- DSG3 antibody ELISA * mPV inadequately managed by at least one standard immunosuppressive therapies * Active mPV at screening * Anti-DSG3 antibody ELISA positive at screening Inclusion Criteria for CABA-201 sub-study: Open to enrollment * Age โ‰ฅ18 * Confirmed diagnosis of PV by prior or screening biopsy and prior positive DSG3 ELISA, IIF, and/or DIF * PV inadequately managed by at least one standard immunosuppressive therapy * Active PV at screening * DSG3 ELISA positive at screening Exclusion Criteria: * Active cutaneous lesions associated with PV that indicates mucocutaneous rather than mucosal-dominant disease * Rituximab in last 12 months unless PV symptoms have recently worsened or anti-DSG3 antibody titers have recently increased * Prednisone \> 0.25mg/kg/day * Other autoimmune disorder requiring immunosuppressive therapies * Investigational treatment in last 3 months Exclusion Criteria for CABA-201 sub-study * Have paraneoplastic pemphigus or active malignancy (not including non-melanoma skin cancer) or malignancy diagnosed within the previous 5 years * Have received rituximab or other anti-CD20 or anti-CD19 therapies in last 12 months unless anti-DSG3 antibody titers have recently increased or PV symptoms have recently worsened * Prednisone \> 0.25mg/kg/day * Other autoimmune disorder requiring immunosuppressive therapies * Treatment with any investigational agent within 4 weeks or 5 half-lives, whichever is longer.
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What it tests

  • DSG3-CAART
  • CABA-201
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Where

13 sites
Stanford University, Dept. of Dermatology
Redwood City, United States
UC Davis, Dept. of Dermatology
Sacramento, United States
Yale University
New Haven, United States
Northwestern University
Chicago, United States
University of Iowa
Iowa City, United States
Brigham and Women's Hospital
Boston, United States
Mount Sinai - Icahn School of Medicine
New York, United States
Columbia University
New York, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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