For Healthcare Professionals

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)

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion 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

Inclusion Criteria for CABA-201 sub-study

  1. Confirmed diagnosis of PV by prior or screening biopsy and prior positive DSG3 ELISA, IIF, and/or DIF
  2. PV inadequately managed by at least one standard immunosuppressive therapy
  3. Active PV at screening
  4. DSG3 ELISA positive at screening

EXCLUSION CRITERIA

Exclusion Criteria:

  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

Exclusion Criteria for CABA-201 sub-study

  1. Have paraneoplastic pemphigus or active malignancy (not including non-melanoma skin cancer)
  2. 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
  3. Prednisone > 0.25mg/kg/day
  4. Other autoimmune disorder requiring immunosuppressive therapies
  5. Investigational treatment in last 3 months
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +1 267 759 3100Email iconEmail Study Center

Study Details


Contition

Pemphigus Vulgaris

Age

18+

Phase

PHASE1

Participants Needed

55

Est. Completion Date

Jan 31, 2029

Treatment Type

INTERVENTIONAL


Sponsor

Cabaletta Bio

ClinicalTrials.gov NCT Identifier

NCT04422912

Study Number

CAB-101

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