RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
← catalyst calendarNCT06121297 · readout ≤ 1,230 d
Sponsored by Cabaletta Bio (industry) · CABA — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
28estimated
Sites
23
Countries
Canada, Spain, 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 | 2024-02-16 | actual | When the study began enrolling |
| Primary completion | Dec 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2023-11-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Systemic Lupus Erythematosus
- Lupus Nephritis
Interventions
- Biological: CABA-201
- Biological: CABA-201
Primary outcome
what the primary-completion date above is the date OFTo evaluate incidence of adverse events
measured Up to 28 days after CABA-201 infusion
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