A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis

ClinicalTrials.gov ID: NCT07335562

Public ClinicalTrials.gov record NCT07335562. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 1:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (Breakfree-SSc)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis

Study identification

NCT ID: NCT07335562
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company; Industry
Enrollment: 92 participants

Conditions and interventions

Conditions

Systemic Sclerosis

Interventions

Drug

Eligibility (public fields only)

Age range: 16 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 28, 2026
Primary completion: Nov 13, 2028
Completion: Nov 10, 2030
Last update posted: Aug 2, 2026

2026 – 2030

United States locations

U.S. sites: 17
U.S. states: 14
U.S. cities: 17

Facility	City	State	ZIP	Site status
Local Institution - 0035	Scottsdale	Arizona	85259	—
University of Colorado Anschutz Medical Campus	Aurora	Colorado	80045	—
Local Institution - 0001	Denver	Colorado	80218	—
Local Institution - 0069	Miami	Florida	33136	—
Emory University School of Medicine	Atlanta	Georgia	30322	—
Local Institution - 0139	Chicago	Illinois	60611	—
Local Institution - 0084	Worcester	Massachusetts	01655	—
Local Institution - 0034	Ann Arbor	Michigan	48109	—
Local Institution - 0037	Rochester	Minnesota	55905	—
Local Institution - 0082	Summit	New Jersey	07901	—
Cleveland Clinic	Cleveland	Ohio	44195	—
Local Institution - 0142	Philadelphia	Pennsylvania	19104	—
Local Institution - 0143	Pittsburgh	Pennsylvania	15224	—
Local Institution - 0002	Charleston	South Carolina	29425	—
Local Institution - 0074	Dallas	Texas	75390	—
Local Institution - 0144	Houston	Texas	77030	—
Local Institution - 0008	Seattle	Washington	98109	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07335562, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 2, 2026 · Synced Sep 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07335562 live on ClinicalTrials.gov.

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