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RECRUITING Phase 1

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 · View on ClinicalTrials.gov ↗

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

Conditions Studied

Interventions

  • BIOLOGICAL CABA-201
  • BIOLOGICAL DSG3-CAART

Study Locations (13)

California

  • Stanford University, Dept. of Dermatology — Redwood City
  • UC Davis, Dept. of Dermatology — Sacramento

New York

  • Mount Sinai - Icahn School of Medicine — New York
  • Columbia University — New York

Texas

  • UT Southwestern Medical Center, Dept. of Dermatology — Dallas
  • MD Anderson Texas Medical Center — Houston

Connecticut

  • Yale University — New Haven

Illinois

  • Northwestern University — Chicago

Iowa

  • University of Iowa — Iowa City

Massachusetts

  • Brigham and Women's Hospital — Boston

North Carolina

  • University of North Carolina, Department of Dermatology — Chapel Hill

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2020-09-29
Est. Completion 2029-01
Phase Phase 1

Sponsor

Cabaletta Bio

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04422912

The ClinicalTrials.gov registry entry for NCT04422912 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cabaletta Bio, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pemphigus Vulgaris appearing as the primary indexed condition, and to 2 interventions — of which CABA-201 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04422912 reports 13 study locations spanning 10 distinct geographic areas — top geographies include California, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04422912 about?

NCT04422912 is a clinical study titled "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)". 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

What is the current status of trial NCT04422912?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2020-09-29. Estimated completion is 2029-01.

What conditions does trial NCT04422912 study?

This clinical trial studies the following conditions: Pemphigus Vulgaris. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04422912?

The interventions under investigation include: CABA-201 (BIOLOGICAL), DSG3-CAART (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04422912?

This trial is sponsored by Cabaletta Bio, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04422912 being conducted?

This trial has 13 study locations across California, Connecticut, Illinois, Iowa, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial