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RecruitingPhase 1/Phase 2

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)

Cabaletta Bio · NCT04422912

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
40
US sites recruiting
10
Study start
September 29, 2020
Record last updated
October 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: DSG3-CAART; CABA-201

Conditions: Pemphigus Vulgaris

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Stanford University, Dept. of Dermatology

    Redwood City, CA 94063

    Site contact: Kunju Sridhar, PhD · 650-721-4902 · kunju@stanford.edu

  • UC Davis, Dept. of Dermatology

    Sacramento, CA 95816

    Site contact: Lauren Downing · 916-551-2635 · ladowning@ucdavis.edu

  • Yale University

    New Haven, CT 06520

    Site contact: Kacie Carlson · 203-785-7432 · kacie.carlson@yale.edu

  • Northwestern University

    Chicago, IL 60611

    Site contact: NU Dermatology CTU · 312-503-5944 · NUderm-research@northwestern.edu

  • University of Iowa

    Iowa City, IA 52242

    Site contact: Amanda Howell · 319-384-6843 · amanda-steahr@uiowa.edu

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Sydney Chase · 617-525-7638 · schase@bwh.harvard.edu

  • Columbia University

    New York, NY 10032

    Site contact: Hei Ton "Jason" Chan · 646-317-6360 · htc2110@cumc.columbia.edu

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Marie DeMarco · 215-349-5699 · marie.demarco@pennmedicine.upenn.edu

  • UT Southwestern Medical Center, Dept. of Dermatology

    Dallas, TX 75235

    Site contact: Aleuna Lee · 214-645-8968 · aleuna.lee@utsouthwestern.edu

  • MD Anderson Texas Medical Center

    Houston, TX 77030

    Site contact: Alda Ashu · 713-792-1280 · abmiraso@mdanderson.org

Study contacts (from the official record)

  • Cabaletta Bio · +1 267 759 3100 · clinicaltrials@cabalettabio.com
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A Phase 1/2, Open-label, Safety and Dosing Study of Autologous… (NCT04422912) | Bored Studies