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NCT04422912 · ClinicalTrials.gov registry record · 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)

A Phase 1 study of Pemphigus Vulgaris, sponsored by Cabaletta Bio.

Recruiting
Registry status
Phase 1
Development phase
40
Enrollment target
13
Study locations

NCT04422912: Recruiting Phase 1 study of Pemphigus Vulgaris, sponsored by Cabaletta Bio.

NCT04422912 is a Phase 1 study of Pemphigus Vulgaris that is actively recruiting participants, run by Cabaletta Bio. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04422912, a Phase 1 study of Pemphigus Vulgaris, is actively recruiting participants, sponsored by Cabaletta Bio.

RECRUITING
Registry status
Phase 1
Development phase
40 participants
Enrollment target
13
Study locations

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

Primary Outcome

Incidence of adverse events that are related to DSG3-CAART therapy

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
Cabaletta Bio

6 total trials

What NCT04422912 shows while recruiting

NCT04422912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

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.

NCT04422912 lists 13 locations in 10 states (California, New York, Texas).

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.

What interventions are being tested in trial NCT04422912?

The interventions under investigation include: CABA-201 (BIOLOGICAL), DSG3-CAART (BIOLOGICAL).

Who is sponsoring clinical trial NCT04422912?

This trial is sponsored by Cabaletta Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Pemphigus Vulgaris

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04422912's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04422912, the US trial registry maintained by the National Library of Medicine. NCT04422912 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.