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KYV-101 anti-CD19 CAR-T cell therapy

Phase 1

Multiple Sclerosis | Monoclonal antibody | Neurology |Kyverna Therapeutics, Inc.|Last Updated: Feb 27, 2026

Success Probability
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12
FDA Designations
FAST_TRACKRMAT
Clinical trial landscape

KYV-101 anti-CD19 CAR-T cell therapy · 3 trials · 7 indications

Phase 1 3
NCT06138132A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple SclerosisMultiple Sclerosis
RECRUITING12 Analytics
NCT05938725KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus NephritisLupus Nephritis
ACTIVE NOT_RECRUITING6 Analytics
NCT06342960KYSA-3: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus NephritisLupus Nephritis
ACTIVE NOT_RECRUITING2 Analytics
PHASE1RECRUITING
A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis
Multiple Sclerosis
NCT0613813212
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PHASE1ACTIVE NOT_RECRUITING
KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
Lupus Nephritis
NCT059387256
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PHASE1ACTIVE NOT_RECRUITING
KYSA-3: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
Lupus Nephritis
NCT063429602
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Study Endpoints
Primary Endpoints
Frequency of dose limiting toxicities at each dose level
Up to 12 months
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
Incidence of adverse events (AEs) including clinical tolerance and laboratory abnormalities
Up to 12 months
To characterize the pharmacokinetics (PK)
Up to 12 months
To characterize the pharmacodynamics (PD)
Up to 12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
KYV-101 CAR-T cells with lymphodepletion conditioningEXPERIMENTALDosing with KYV-101 CAR T cells
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
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patient is ≥ 18 years old, and ≤65 years of age, at time of screening visit. 2. Diagnosis of MS according to the 2017 McDonald Criteria. 3. Progressive MS by 2014 Lublin MS phenotypic criteria. 4. Presence of varicella-zoster virus (VZV) antibodies, or completion of at least ...

Countries:United StatesGermany
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Competitive Landscape -Multiple Sclerosis 97 trials

Top 20 of 21 competitors

CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY6PHASE3Frexalimab, MRI contrast-enhancing agents
Bristol-Myers Squibb CompanyBMY8PHASE3Ozanimod, Fingolimod
Novartis AG Sponsored ADRNVS23PHASE3Remibrutinib, Teriflunomide
Biogen Inc.BIIB6PHASE3BIIB017, Interferon beta type 1a
Zenas BioPharma, Inc.ZBIO3PHASE3Orelabrutinib
TG Therapeutics, Inc.TGTX8PHASE3Ublituximab
Immunic, Inc.IMUX3PHASE3IMU-838
Amgen Inc.AMGN1PHASE3Ocrelizumab, ABP 692
Eli Lilly and CompanyLLY1PHASE2LY3541860
Moderna, Inc.MRNA1PHASE2mRNA-1195
Kyverna Therapeutics, Inc.KYTX3PHASE2KYV-101, Standard lymphodepletion regimen, Anti-CD20 mAB
Hoffmann-La RocheRHHBY1PHASE3Ocrelizumab, Fingolimod
Tiziana Life Sciences Ltd.TLSA2PHASE2Foralumab
Supernus Pharmaceuticals, Inc.SUPN1PHASE2Phase 2; Low Dose MYOBLOC, Phase 3; MYOBLOC
AstraZeneca PLCAZN1PHASE1AZD0120 - Regimen 1, AZD0120 - Regimen 2
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE1Obecabtagene autoleucel
TScan Therapeutics, Inc.TCRX1 - Undisclosed
Merck & Co., Inc.MRK1 - Mavenclad
Solana Company Class AHSDT1 - Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05938725primaryCompletionDate: changed
LOWMay 26, 2026NCT06342960primaryCompletionDate: changed
LOWMay 24, 2026NCT06138132studyFirstPostDate: changed
LOWMay 24, 2026NCT06342960studyFirstPostDate: changed
LOWMay 24, 2026NCT05938725studyFirstPostDate: changed