A Phase 2/3 interventional study of CABA-201 and CABA-201 in Systemic Sclerosis, Scleroderma and Interstitial Lung Diseases, sponsored by Cabaletta Bio. Recruiting at 10 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Cabaletta Bio · Phase 2/3, Interventional, and Treatment
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
Systemic sclerosis (SSc), also known as scleroderma , is a rare autoimmune disorder characterized by autoantibody production and abnormal B cell function. Though the cause of SSc is not well understood, it is thought to involve B cells that cause the body to attack different tissues in one's own body, causing skin and organ fibrosis. This study is being conducted to evaluate the safety and efficacy of an investigational therapy, CABA-201, a CD19-CAR T cell therapy, that can be given to patients with SSc who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 37 is close to the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Cabaletta Bio is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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Severe Skin Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with severe skin involvement Organ Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with organ involvement
Biological: CABA-201
Infusion of CABA-201 with preconditioning in subjects with SSc
Biological: CABA-201
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Also known as: Rese-cel, Resecabtagene autoleucel
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Also known as: Rese-cel, Resecabtagene autoleucel
Phase 1/2: To evaluate incidence of adverse events
Incidence and severity of AEs
Time frame: Up to 28 days after CABA-201 infusion
Phase 2b Sub-study: To evaluate the efficacy of CABA-201 on % predicted forced vital capacity (FVC) in SSc-ILD subjects
Mean change from baseline in % predicted FVC without any immunomodulatory or anti-fibrotic medications and on no or low dose of steroids
Time frame: Week 52
To evaluate adverse events and laboratory abnormalities
Incidence and severity of AEs, including changes in laboratory values and vital signs
Time frame: Up to 156 weeks (Phase 1/2) and through 104 weeks (Sub-study)
To characterize the pharmacodynamics (PD)
Levels of B cells in the blood
Time frame: Up to 156 weeks (Phase 1/2) and through 104 weeks (Sub-study)
To characterize the pharmacokinetics (PK)
Levels of CABA-201-positive T cells in the blood
Time frame: Up to 156 weeks (Phase 1/2) and through 104 weeks (Sub-study)
To evaluate efficacy
Proportion of subjects achieving revised Composite Response Index for Systemic Sclerosis (CRISS) criteria
Time frame: Up to 156 weeks (Phase 1/2) and at Week 52 (Sub-study)
Mean change from baseline in Modified Rodnan Skin Score (mRSS)
Time frame: Week 52 (Sub-study)
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Jul 2029, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Autologous Anti-CD19 CAR-T Cells CABA-201
Cabaletta Bio