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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-09-29 |
| Est. Completion | 2029-01 |
| Phase | Phase 1 |
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.
Learn More About Clinical Trials
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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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