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)
NCT ID: NCT04422912
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2020-09-29
2029-01-31
Brief Summary
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Detailed Description
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This phase 1/2 study is being conducted in two parts. The first part is the main study 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 mucosal PV who are inadequately managed by standard therapies. This study is closed to enrollment.
The second part is a sub-study is being conducted to investigate if CABA-201, also called resecabtagene autoleucel, or "rese-cel", can be safely administered while achieving clinical responses without the need for preconditioning in mucosal-dominant PV (mPV) and mucocutaneous PV (mcPV) patients. This sub-study is open to enrollment.
DSG3-CAART or CABA-201 may potentially lead to complete and durable remission of disease.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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DSG3-CAART
Single or multiple intravenous infusion(s) of DSG3-CAART at varying dose levels.
This study is now closed to enrollment.
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
Infusion of CABA-201 with or without cyclophosphamide and fludarabine preconditioning, or with or without cyclophosphamide preconditioning.
This sub-study is open to enrollment.
CABA-201
Single intravenous infusion of CABA-201 at escalating doses, with or without preconditioning.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* mPV inadequately managed by at least one standard immunosuppressive therapies
* Active mPV at screening
* Anti-DSG3 antibody ELISA positive at screening
* 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
* 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
* 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.
18 Years
ALL
No
Sponsors
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Cabaletta Bio
INDUSTRY
Responsible Party
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Principal Investigators
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Cabaletta Bio
Role: STUDY_CHAIR
Cabaletta Bio
Locations
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Stanford University, Dept. of Dermatology
Redwood City, California, United States
UC Davis, Dept. of Dermatology
Sacramento, California, United States
Yale University
New Haven, Connecticut, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mount Sinai - Icahn School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
University of North Carolina, Department of Dermatology
Chapel Hill, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center, Dept. of Dermatology
Dallas, Texas, United States
MD Anderson Texas Medical Center
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CAB-101
Identifier Type: -
Identifier Source: org_study_id