RECRUITING

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)

Description

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

Conditions

Pemphigus Vulgaris
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Related Conditions:

Pemphigus Vulgaris

Study Overview

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Study Details

Study overview

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

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

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)

Condition
Pemphigus Vulgaris
Intervention / Treatment

-

Contacts and Locations

Redwood City

Stanford University, Dept. of Dermatology, Redwood City, California, United States, 94063

Sacramento

UC Davis, Dept. of Dermatology, Sacramento, California, United States, 95816

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

New York

Mount Sinai - Icahn School of Medicine, New York, New York, United States, 10029

Chapel Hill

University of North Carolina, Department of Dermatology, Chapel Hill, North Carolina, United States, 27516

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Dallas

UT Southwestern Medical Center, Dept. of Dermatology, Dallas, Texas, United States, 75235

Houston

MD Anderson Texas Medical Center, Houston, Texas, United States, 77030

Seattle

University of Washington, Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * 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
  • * Have paraneoplastic pemphigus or active malignancy (not including non-melanoma skin cancer)
  • * 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
  • * Investigational treatment in last 3 months

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cabaletta Bio,

Cabaletta Bio, STUDY_CHAIR, Cabaletta Bio

Study Record Dates

2029-01