A Phase 1, Open-Label, Single Center Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis
Stanford University
Summary
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy in Subjects with Non-relapsing and Progressive Forms of Multiple Sclerosis
Description
Multiple Sclerosis (MS) is an immune-mediated neurodegenerative central nervous system disease that can lead to loss of vital neurologic function. The clinical course of MS from person to person is variable. Progressive Multiple Sclerosis (pMS) is marked by a history of neurologic worsening over time; and can occur following a prior history of defined relapses that has evolved to a non-relapsing state (previously termed "secondary progressive MS" (SPMS)) or from disease onset (termed "primary progressive MS" (PPMS)). There are now more than twenty FDA approved disease modifying therapies (DMT…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 one dose of the varicella zoster glycoprotein E (gE) Shingrix vaccine at least four weeks prior to treatment. 5. Presence of anti EBV antibodies. 6. Organ and Marrow Function * Absolute neutrophil count (ANC) ≥ 2000/uL. * Platelet count ≥ 150,000/uL. * Absolute lymphocyte count ≥ 1000/uL.…
Interventions
- BiologicalKYV-101 anti-CD19 CAR-T cell therapy
KYV-101 anti-CD19 CAR-T cell therapy
- DrugStandard lymphodepletion regimen
Standard lymphodepletion regimen
Location
- Stanford Multiple Sclerosis CenterPalo Alto, California