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KYV-101

Phase 3Cell therapy

KKyverna Therapeutics

KYV-101 is one of 81 biologic programs targeting Myasthenia Gravis. It is currently in Phase 3.

4

Indications

9

Total Trials

6

Active Trials

80

Competitors

Pipeline

Status by Indication[3][1]

Indication

Myasthenia GravisRecruiting

Multiple SclerosisRecruiting

Secondary Progressive Multiple SclerosisActive, not recruiting

DermatomyositisRecruiting

Myasthenia GravisPhase 3

Recruiting

Multiple SclerosisPhase 1

Recruiting

Secondary Progressive Multiple SclerosisPhase 2

Active, not recruiting

DermatomyositisPhase 1

Recruiting

Competition

Competitive Landscape

138 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Rinvoq

Cytoxan

BBaxter Healthcare Corporation

Questran

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Clemastine Fumarate

Mayzent

Activated Charcoal

Antihistamine

Arrowhead Pharmaceuticals

MRI Contrast-Enhancing Agents

Frexalimab

Tolebrutinib

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1Active, not recruiting

Idiopathic Inflammatory Myopathies

NCT06152172

Q2 2027

Phase 1Recruiting

Multiple Sclerosis

NCT06138132

Q3 2028

PreclinicalRecruiting

Myasthenia Gravis

NCT06193889

Q1 2029

Phase 2Active, not recruiting

Secondary Progressive Multiple Sclerosis

NCT06384976

Clinical

Trials by Indication[1]

Lupus Nephritis2 trials

KYSA-3: A Phase 1/2, Open-Label, Multicenter Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis

Terminated·KKyverna Therapeutics·Preclinical·NCT06342960·2 enrolled

KYSA-1: A Phase 1/2, Open-Label, Multicenter Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis

Terminated·KKyverna Therapeutics·Preclinical·NCT05938725·6 enrolled

Long-term Follow-up1 trial

A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101

Recruiting·KKyverna Therapeutics··NCT07403188·70 enrolled

Multiple Sclerosis1 trial

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis

Recruiting·SStanford University·Phase 1·NCT06138132·12 enrolled

Dermatomyositis1 trial

Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis

Recruiting·SStanford University·Phase 1·NCT06298019·21 enrolled

Secondary Progressive Multiple Sclerosis1 trial

KYSA-7: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis

Active, not recruiting·KKyverna Therapeutics·Phase 2·NCT06384976·120 enrolled

3 more indications

Idiopathic Inflammatory Myopathies1 trial

CARTIMMUNE: A Single-Center Study of Patients With Autoimmune Diseases Receiving an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (KYV 101)

Active, not recruiting·DDavid Porter·Phase 1·NCT06152172·24 enrolled

Systemic Sclerosis1 trial

KYSA-5: A Phase 1/2, Open-Label, Multicentre Study of KYV 101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis

Terminated·KKyverna Therapeutics·Preclinical·NCT06400303·3 enrolled

Myasthenia Gravis1 trial

KYSA-6: A Phase 2/3, Open-Label, Randomized, Controlled, Multicenter Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-cell (CD19 CAR T) Therapy, Versus Ongoing Standard-Of-Care Immunosuppressive Therapy in Patients With Generalized Myasthenia Gravis

Recruiting·KKyverna Therapeutics·Preclinical·NCT06193889·66 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for KYV-101. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — KYV-101 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for KYV-101. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Kyverna Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Cell therapy[2]
Highest Phase: Phase 3[1]
Company: KKyverna Therapeutics

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