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Open-label Study to Determine the Maximum Tolerated Dose of DSG3-CAART in Mucosal-dominant PV Patients (mPV)

Open-label Study to Determine the Maximum Tolerated Dose of DSG3-CAART in Mucosal-dominant PV Patients (mPV)

Recruiting
18 years and older
All
Phase 1

Overview

Mucosal-dominant pemphigus vulgaris (mPV) is a B-cell mediated autoimmune disorder in which painful blisters are formed on the mucosal membrane, including the mouth, nose, throat, eyelids, anus, and genitals. This phase 1 study is being conducted to find the maximum tolerated dose and optimal fractionated infusion schedule of an investigational cell therapy, DSG3-CAART, that can be given to patients with mPV who are inadequately managed by standard therapies. DSG3-CAART may potentially lead to complete and durable remission of disease.

Eligibility

Inclusion Criteria:

  • Confirmed diagnosis of mPV by prior biopsy and prior positive DSG3 ELISA
  • mPV inadequately managed by at least two standard immunosuppressive therapies
  • Active mPV at screening
  • DSG3 ELISA positive at screening

Exclusion Criteria:

  • Cutaneous lesions associated with PV
  • Rituximab in last 6 months
  • Prednisone > 0.25mg/kg/day
  • Other autoimmune disorder requiring immunosuppressive therapies
  • Investigational treatment in last 6 months
  • Absolute lymphocyte count < 1,000/L at screening

Study details
    Mucosal -Dominant Pemphigus Vulgaris

NCT04422912

Cabaletta Bio

16 February 2024

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