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RESET-SSc: CABA-201 for Systemic Sclerosis

This study, called RESET-SSc, is testing a new treatment called CABA-201 for people with systemic sclerosis (scleroderma). Scleroderma is a rare condition where your body's immune system attacks its own tissues, causing scarring in the skin and organs. CABA-201 is a type of CAR T cell therapy, which means it uses your own immune cells, specially modified, to target certain cells in your body. Researchers believe that CABA-201, given as a single infusion after some other medications (fludarabine and cyclophosphamide), might help by targeting specific immune cells (B cells) that are thought to cause scleroderma. This study aims to see how safe CABA-201 is and if it helps improve the condition. It is looking for about 12 participants between 18 and 75 years old who have active scleroderma affecting their skin or organs. The study's status is currently unclear regarding recruitment.

Study design
This is an open-label study, meaning you and your doctors will know what treatment you are receiving. It plans to enroll 12 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate side effects for up to 28 days after you receive the CABA-201 infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06328777

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Cabaletta Bio
~37 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:CABA-201

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1/2: To evaluate incidence of adverse events
Measured over Up to 28 days after CABA-201 infusion
+1 more outcome measured

Conditions

Systemic Sclerosis
Scleroderma
Interstitial Lung Diseases

Explore related trials

Systemic Scleroderma

Where it's being run

10 sites across 8 states
Illinois2
New York2
Connecticut1
Florida1
Kansas1
Michigan1
Minnesota1
North Carolina1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Cabaletta Bio

Who to contact

Cabaletta Bio
[email protected]
267 759 3100 · ext. 4444
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥18 and ≤75
A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria.
Early active disease
Evidence of significant skin, pulmonary, or cardiac involvement

Exclusion

Contraindication to leukapheresis
History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites
Active infection requiring medical intervention at screening visit
Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
Severe lung or cardiac impairment
Previous CAR T cell therapy
Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant

What this trial measures

  • Phase 1/2: To evaluate incidence of adverse eventsUp to 28 days after CABA-201 infusion

    Incidence and severity of AEs

  • Phase 2b Sub-study: To evaluate the efficacy of CABA-201 on % predicted forced vital capacity (FVC) in SSc-ILD subjectsWeek 52

    Mean change from baseline in % predicted FVC without any immunomodulatory or anti-fibrotic medications and on no or low dose of steroids