KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
← catalyst calendarNCT05938725 · readout ≤ 12 d
Sponsored by Kyverna Therapeutics (industry) · KYTX — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
6actual
Sites
6
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 | 2023-04-28 | actual | When the study began enrolling |
| Primary completion | Aug 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2023-07-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Lupus Nephritis
- Lupus Nephritis - World Health Organization (WHO) Class III
- Lupus Nephritis - WHO Class IV
Interventions
- Biological: KYV-101 anti-CD19 CAR-T cell therapy
- Drug: Standard lymphodepletion regimen — also filed as Cyclophosphamide, Fludarabine
Primary outcomes
what the primary-completion date above is the date OFIncidence adverse events (AEs) and laboratory abnormalities (Phase 1 and Phase 2)
measured Up to 2 years
Frequency of dose limiting toxicities at each dose level (Phase 1)
measured Up to 2 years
To Evaluate efficacy (Phase 2)
measured Up to 52 Weeks
Publications
- PMID 31959992 — cited as background
- PMID 36109639 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · KYTX's whole pipeline · Catalyst calendar · Every registered study · What changed