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

  • STATUS
    Recruiting
  • End date
    Aug 5, 2026
  • participants needed
    30
  • sponsor
    Cabaletta Bio
Updated on 19 February 2024

Summary

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.

Details
Condition Mucosal -Dominant Pemphigus Vulgaris
Age 18-100 years
Treatment DSG3-CAART
Clinical Study IdentifierNCT04422912
SponsorCabaletta Bio
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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