Recent Updates
Recently added Catalysts

KYV-101 anti-CD19 CAR-T cell therapy

Phase 1

Lupus Nephritis | Monoclonal antibody | Immunology |Kyverna Therapeutics, Inc.|Last Updated: Oct 29, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05938725KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus NephritisPHASE1 ACTIVE NOT_RECRUITING 6 — — Apr 28, 2023Aug 1, 2027Oct 29, 20256 United States
NCT06342960KYSA-3: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus NephritisPHASE1 ACTIVE NOT_RECRUITING 2 — — Dec 1, 2022Jan 1, 2029Oct 29, 20256 Germany
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence adverse events (AEs) and laboratory abnormalities (Phase 1 and Phase 2)
Up to 2 years
Frequency of dose limiting toxicities at each dose level (Phase 1)
Up to 2 years
To Evaluate efficacy (Phase 2)
Up to 52 Weeks

Complete renal response rates (CRR)

Frequency of dose limiting toxicities (Phase 1)
Up to 2 years
Secondary Endpoints
To characterize the pharmacokinetics (PK) (Phase 1 and Phase 2)
Up to 2 years
To characterize the pharmacodynamics (PD) (Phase 1 and Phase 2)
Up to 2 years
To evaluate disease related biomarkers (Phase 1 and Phase 2)
Up to 2 years
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1)EXPERIMENTALDosing with KYV-101 CAR T cells
KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2)EXPERIMENTALRecommended Phase 2 Dose
Interventions
NameTypeDescription
KYV-101 anti-CD19 CAR-T cell therapyBIOLOGICALKYV-101 anti-CD19 CAR-T cell therapy
Standard lymphodepletion regimenDRUGStandard lymphodepletion regimen
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Age ≥18 years 2. Clinical diagnosis of SLE according to 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria 3. Biopsy-proven proliferative LN Class III or IV according to 2018 International Society of Nephrology/Renal P...

Countries:United StatesGermany
Unlock Eligibility Criteria
Competitive Landscape -Lupus Nephritis 26 trials
CompanyTickerTrialsLead PhaseDrugs
Novartis AG Sponsored ADRNVS5PHASE3ianalumab s.c. q4w, ianalumab s.c. q12w, Ianalumab, rapcabtagene autoleucel, Iptacopan
Viatris, Inc.VTRS1PHASE3Cenerimod
AstraZeneca PLCAZN2PHASE3Anifrolumab, Ravulizumab
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2Obecabtagene autoleucel
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Bristol-Myers Squibb CompanyBMY1PHASE2CC-97540, Fludarabine, Cyclophosphamide
Regeneron Pharmaceuticals, Inc.REGN1PHASE1Vonsetamig, Odronextamab
Kyverna Therapeutics, Inc.KYTX3PHASE1KYV-101 anti-CD19 CAR-T cell therapy, Standard lymphodepletion regimen, KYV-101
CRISPR Therapeutics AGCRSP1PHASE1CTX112
Artiva Biotherapeutics, Inc.ARTV1PHASE1AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab
Cabaletta Bio, Inc.CABA1PHASE1CABA-201
Vertex Pharmaceuticals IncorporatedVRTX1PHASE1Povetacicept
Adicet Bio IncACET1PHASE1ADI-001, Fludarabine, Cyclophosphamide
Fate Therapeutics, Inc.FATE1PHASE2FT819
Nkarta, Inc.NKTX1PHASE1NKX019, Fludarabine, Cyclophosphamide
Century Therapeutics, Inc.IPSC1PHASE1CNTY-101, IL-2, Lymphodepleting Chemotherapy
GSK plc Sponsored ADRGSK1 — Undisclosed
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05938725primaryCompletionDate: changed
LOWMay 26, 2026NCT06342960primaryCompletionDate: changed
LOWMay 24, 2026NCT06342960studyFirstPostDate: changed
LOWMay 24, 2026NCT05938725studyFirstPostDate: changed