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KYV-101 in Refractory Lupus Nephritis
NCT06342960Phase 2
Key facts
- Status
- Terminated
- Start
- Dec 2022
- Primary completion
- Dec 2025
- Countries
- 1
- Sponsor
- Kyverna Therapeutics
- Modality
- CAR-T Cells
- Conditions
- lupus nephritis (LN)
01
Overview
Phase 2, open-label trial of mivocabtagene autoleucel in lupus nephritis (LN) (2 arms), sponsored by Kyverna Therapeutics. Primary endpoints: Incidence of adverse events and laboratory abnormalities at 2 years and Frequency of dose limiting toxicities at 2 years. Started Dec 2022; status: terminated.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Phase 1
KYV-101 CAR-T cells with lymphodepletion conditioning
Phase 2
KYV-101 CAR-T cells with lymphodepletion conditioning at Recommended Phase 2 Dose
03
Who it enrols
Adults with refractory proliferative lupus nephritis (Class III or IV) and positive autoantibodies, excluding those with severe CNS lupus, prior cell/gene therapy, or active infections.
04
Endpoints
Primary
Incidence of adverse events and laboratory abnormalities
Frequency of dose limiting toxicities
Secondary
Pharmacokinetics
Pharmacodynamics
Disease related biomarkers
Efficacy of KYV-101
Immunogenicity (humoral response)
Patient Related Outcome
Recommended Phase 2 dose
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