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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2020-09-29
Study Completion:2029-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04422912

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of mPV by prior or screening biopsy and prior positive anti- DSG3 antibody ELISA
  2. * mPV inadequately managed by at least one standard immunosuppressive therapies
  3. * Active mPV at screening
  4. * Anti-DSG3 antibody ELISA positive at screening
  5. * Confirmed diagnosis of PV by prior or screening biopsy and prior positive DSG3 ELISA, IIF, and/or DIF
  6. * PV inadequately managed by at least one standard immunosuppressive therapy
  7. * Active PV at screening
  8. * DSG3 ELISA positive at screening
  1. * Active cutaneous lesions associated with PV that indicates mucocutaneous rather than mucosal-dominant disease
  2. * Rituximab in last 12 months unless PV symptoms have recently worsened or anti-DSG3 antibody titers have recently increased
  3. * Prednisone \> 0.25mg/kg/day
  4. * Other autoimmune disorder requiring immunosuppressive therapies
  5. * Investigational treatment in last 3 months
  6. * Have paraneoplastic pemphigus or active malignancy (not including non-melanoma skin cancer)
  7. * 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
  8. * Prednisone \> 0.25mg/kg/day
  9. * Other autoimmune disorder requiring immunosuppressive therapies
  10. * Investigational treatment in last 3 months

Contacts and Locations

Study Contact

Cabaletta Bio
CONTACT
+1 267 759 3100
clinicaltrials@cabalettabio.com

Principal Investigator

Cabaletta Bio
STUDY_CHAIR
Cabaletta Bio

Study Locations (Sites)

Stanford University, Dept. of Dermatology
Redwood City, California, 94063
United States
UC Davis, Dept. of Dermatology
Sacramento, California, 95816
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Mount Sinai - Icahn School of Medicine
New York, New York, 10029
United States
University of North Carolina, Department of Dermatology
Chapel Hill, North Carolina, 27516
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
UT Southwestern Medical Center, Dept. of Dermatology
Dallas, Texas, 75235
United States
MD Anderson Texas Medical Center
Houston, Texas, 77030
United States
University of Washington
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Cabaletta Bio

  • Cabaletta Bio, STUDY_CHAIR, Cabaletta Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-29
Study Completion Date2029-01

Study Record Updates

Study Start Date2020-09-29
Study Completion Date2029-01

Terms related to this study

Keywords Provided by Researchers

  • Pemphigus
  • Pemphigus Vulgaris
  • CAAR-T Therapy
  • CAR-T Therapy
  • Desmoglein 3
  • Cell Therapy
  • Autoimmune Disease
  • Autoimmunity
  • Skin Diseases, Vesiculobullous
  • Immunotherapy, Adoptive
  • Immune System Diseases
  • CABA-201
  • Anti-CD19 CAR-T therapy

Additional Relevant MeSH Terms

  • Pemphigus Vulgaris