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NCT06328777 · ClinicalTrials.gov registry record · Phase 1
RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
A Phase 1 study of Systemic Sclerosis and Scleroderma, sponsored by Cabaletta Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 10
- Study locations
NCT06328777: Recruiting Phase 1 study of Systemic Sclerosis and Scleroderma, sponsored by Cabaletta Bio.
NCT06328777 is a Phase 1 study of Systemic Sclerosis and Scleroderma that is actively recruiting participants, run by Cabaletta Bio. The registered enrollment target is 12 participants, below the 279-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06328777, a Phase 1 study of Systemic Sclerosis and Scleroderma, is actively recruiting participants, sponsored by Cabaletta Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 10
- Study locations
Study Summary
RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis
Primary Outcome
Incidence and severity of AEs
Conditions Studied
Interventions
- BIOLOGICAL CABA-201
Study Locations (10)
Illinois
- Northwestern Memorial Hospital - Chicago
- The University of Chicago Medical Center - Chicago
New York
- Columbia University Irving Medical Center - New York
- University of Rochester - Rochester
Connecticut
- Yale University - New Haven
Florida
- Mayo Clinic Florida - Jacksonville
Kansas
- University of Kansas Medical Center - Kansas City
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic Rochester - Rochester
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-07-02 |
| Est. Completion | 2029-07 |
| Phase | Phase 1 |
What NCT06328777 shows while recruiting
NCT06328777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 279-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Systemic Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which CABA-201 is the first listed.
NCT06328777 lists 10 locations in 8 states (Illinois, New York, Connecticut).
Frequently Asked Questions
What is clinical trial NCT06328777 about?
NCT06328777 is a clinical study titled "RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis". RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis
What is the current status of trial NCT06328777?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-07-02. Estimated completion is 2029-07.
What conditions does trial NCT06328777 study?
This clinical trial studies the following conditions: Systemic Sclerosis, Scleroderma.
What interventions are being tested in trial NCT06328777?
The interventions under investigation include: CABA-201 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06328777?
This trial is sponsored by Cabaletta Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06328777 being conducted?
This trial has 10 study locations across Connecticut, Florida, Illinois, Kansas, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Sclerosis
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 NCT06328777's enrollment target sits among peer trials
12 23rd of 26 higher than 3 of 26 other Systemic Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Sclerosis 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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