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KYV-101

Phase 2

Multiple Sclerosis, Primary Progressive | Monoclonal antibody | Immunology |Kyverna Therapeutics, Inc.|Last Updated: Jan 13, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06384976KYSA-7: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple SclerosisPHASE2 ACTIVE NOT_RECRUITING 120Sep 20, 2024Jan 1, 2029Jan 13, 20251 United States
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Study Endpoints
Primary Endpoints
To evaluate efficacy of KYV-101
at least 12 weeks

Confirmed disability Progression on the EDSS scale. The EDSS scale ranges from 0 to 10 in 0.5- unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.

Secondary Endpoints
To characterize the safety and tolerability of KYV-101
Up to 2 years
To evaluate efficacy of KYV-101
up to 12 weeks
To characterize the pharmacokinetics (PK)
Up to 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
KYV-101 CAR-T cells with lymphodepletion conditioningEXPERIMENTALDosing with KYV-101 CAR T cells
Anti- CD20 mAbACTIVE_COMPARATORDosing with anti-CD20 mAb
Interventions
NameTypeDescription
KYV-101BIOLOGICALAnti-CD19 CAR-T cell therapy
Standard lymphodepletion regimenDRUGCYC/FLU
Anti-CD20 mABDRUGAnti-CD20 mAB
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: 1. Subject must have a history of diagnosis of primary progressive or secondary progressive MS. 2. History of treatment with anti-CD20 mAb with continuing evidence of worsening physical disability over a period of ≥6 months, with documented clinical disability progression wi...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06384976primaryCompletionDate: changed
LOWMay 24, 2026NCT06384976studyFirstPostDate: changed