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Clinical Trials in the USA / NCT04422912
Recruiting Phase 1/2

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)

NCT04422912 · tracked via the Priya Life Science USA tracker
Sponsor
Cabaletta Bio
Phase
Phase 1/2
Started
2020-09-29
Last updated
2026-05-29

Condition(s) studied

Pemphigus Vulgaris

Investigational drug(s) / intervention(s)

DSG3-CAARTCABA-201

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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Stanford University, Dept. of Dermatology Redwood City California Recruiting
UC Davis, Dept. of Dermatology Sacramento California Recruiting
Yale University New Haven Connecticut Recruiting
Northwestern University Chicago Illinois Recruiting
University of Iowa Iowa City Iowa Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
Mount Sinai - Icahn School of Medicine New York New York Withdrawn
Columbia University New York New York Recruiting
University of North Carolina, Department of Dermatology Chapel Hill North Carolina Withdrawn
University of Pennsylvania Philadelphia Pennsylvania Recruiting
UT Southwestern Medical Center, Dept. of Dermatology Dallas Texas Recruiting
MD Anderson Texas Medical Center Houston Texas Recruiting
University of Washington Seattle Washington Completed

More Cabaletta Bio trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04422912 on ClinicalTrials.gov ↗ ← All trials in the USA