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
← catalyst calendarNCT06328777 · readout ≤ 1,077 d
Sponsored by Cabaletta Bio (industry) · CABA — their whole pipeline →.
Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
37estimated
Sites
10
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-07-02 | actual | When the study began enrolling |
| Primary completion | Jul 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2024-03-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Systemic Sclerosis
- Scleroderma
- Interstitial Lung Diseases
Interventions
- Biological: CABA-201 — also filed as Rese-cel, Resecabtagene autoleucel
- Biological: CABA-201 — also filed as Rese-cel, Resecabtagene autoleucel
Primary outcomes
what the primary-completion date above is the date OFPhase 1/2: To evaluate incidence of adverse events
measured 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
measured Week 52
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