Recruiting

Phase 1

Phase 2

DSG3-CAART & CABA-201A 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)

Sponsor:

Cabaletta Bio

Code:

NCT04422912

Conditions

Pemphigus Vulgaris

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DSG3-CAART

CABA-201

Study Details

Brief summary:

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

Conditions

Pemphigus Vulgaris

Study ID

NCT04422912

Start date

Sep 29, 2020

Status verified date

May, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DSG3-CAART

Single or multiple intravenous infusion(s) of DSG3-CAART at varying dose levels.

This study is now closed to enrollment.

experimental: CABA-201

Infusion of CABA-201 with or without cyclophosphamide and fludarabine preconditioning, or with or without cyclophosphamide preconditioning.

This sub-study is open to enrollment.

Interventions

DSG3-CAART

Intravenous infusions of DSG3-CAART alone at different doses and different fractionations, with or without intravenous immunoglobulin, cyclophosphamide, and/or fludarabine.

CABA-201

Single intravenous infusion of CABA-201 at escalating doses, with or without preconditioning.

Primary outcome measure

Adverse events, including Dose Limit Toxicity [ Time Frame: 3 months ]
For CABA-201 Sub-study: To evaluate adverse events reported by subjects [ Time Frame: Up to 28 days after CABA-201 infusion ]

Central Contacts and Locations

Central contacts

Cabaletta Bio

+1 267 759 3100 clinicaltrials@cabalettabio.com

Locations

Stanford University, Dept. of Dermatology

Recruiting

Redwood City, California, United States, 94063

Contacts

Kunju Sridhar, PhD

650-721-4902 kunju@stanford.edu

Principal Investigator:

M. Peter Marinkovich, MD

UC Davis, Dept. of Dermatology

Recruiting

Sacramento, California, United States, 95816

Contacts

Lauren Downing

916-551-2635 ladowning@ucdavis.edu

Principal Investigator:

Mehrdad Abedi, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Andrea DeClement

475-255-8031 andrea.declement@yale.edu

Principal Investigator:

Mary Tomayko, MD, PhD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

NU Dermatology CTU

312-503-5944 NUderm-research@northwestern.edu

Principal Investigator:

Alan Zhou, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Amanda Howell

319-384-6843 amanda-steahr@uiowa.edu

Principal Investigator:

Emma Killoran, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sydney Chase

617-525-7638 schase@bwh.harvard.edu

Rebecca Wenzel-Rideout

rwenzel-rideout@bwh.harvard.edu

Principal Investigator:

Arash Mostaghimi, MD, MPH, FAAD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Hei Ton "Jason" Chan

646-317-6360 htc2110@cumc.columbia.edu

Principal Investigator:

Alexandra Coromilas, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Marie DeMarco

215-349-5699 marie.demarco@pennmedicine.upenn.edu

Principal Investigator:

David Porter, MD

UT Southwestern Medical Center, Dept. of Dermatology

Recruiting

Dallas, Texas, United States, 75235

Contacts

Aleuna Lee

214-645-8968 aleuna.lee@utsouthwestern.edu

Principal Investigator:

Arturo Dominguez, MD

MD Anderson Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Alda Ashu

713-792-1280 abmiraso@mdanderson.org

Principal Investigator:

Omar Pacha, MD

More Information

Sponsor

Cabaletta Bio

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

Pemphigus
Pemphigus Vulgaris
CAAR-T Therapy
CAR-T Therapy
Desmoglein 3
Cell Therapy
Autoimmune Disease
Autoimmunity
Skin Diseases, Vesiculobullous
Immunotherapy, Adoptive
Immune System Diseases
CABA-201
Anti-CD19 CAR-T therapy
Resecabtagene Autoleucel
Rese-cel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Cabaletta Bio on 2026-05-29.