Investigating a new cell therapy for pemphigus vulgaris

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 open-label study evaluates the safety and dosing of autologous CART cells, specifically DSG3-CAART and CABA-201, in patients with active pemphigus vulgaris who have not responded adequately to standard treatments. The study aims to determine the maximum tolerated dose and optimal infusion schedule for DSG3-CAART, while also assessing the safety and efficacy of CABA-201 without preconditioning. Patients will be monitored for clinical responses and potential remission of their disease.

Why it matters

Who can join: the full rules

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 ≥18
* 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.

Where it's running

• Stanford University, Dept. of Dermatology
  Redwood City, California, United States Recruiting
• UC Davis, Dept. of Dermatology
  Sacramento, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• University of Iowa
  Iowa City, Iowa, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Cabaletta Bio
• Email: clinicaltrials@cabalettabio.com
• Phone: +1 267 759 3100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.