drugset / Trial / NCT06451159

A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis

NCT06451159

Phase 1 Active not recruiting 10 enrolled Bruce Cree Kyverna Therapeutics · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

The goal of this study is to test a drug called KYV-101 in people who have progressive multiple sclerosis (MS) and who have not responded to standard therapies to slow disease progression. The main questions it aims to answer are: * What is the highest therapy dose that can be given without causing harm? * Can this therapy enter the central nervous system? Participants will be asked to: * Attend 14 visits plus an 8-day inpatient hospital stay over the course of 58 weeks. * Complete apheresis and chemotherapy treatments in preparation for KVY-101 therapy. * Undergo medical and research testing such as physical and neurological exams, MRI, lumbar puncture, blood draws, questionnaires, and vision assessments.

Timeline

Start
2024-06-20
Primary completion
2026-02
Completion
2027-02

Drugs

EvaluationDrugModalityDoseRoute
Subject KYV-101 Cell therapy 3.3e+07 cells
Subject KYV-101 Cell therapy 1e+08 cells
Background Cyclophosphamide Other / unclassified 300 mg/m2
Background Fludarabine Small molecule 30 mg/m2

Indications