A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy in Subjects with Non-relapsing and Progressive Forms of Multiple Sclerosis
Patient is ≥ 18 years old, and ≤65 years of age, at time of screening visit.
Diagnosis of MS according to the 2017 McDonald Criteria.
Progressive MS by 2014 Lublin MS phenotypic criteria.
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.
History of neuromyelitis optica spectrum disorder (NMOSD) or MOG antibody associated disease (MOGAD).
Prior treatment with any investigational agent within 3 months, or 5 half-lives, whichever is longer. Agents authorized by the FDA for prevention or treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are not considered investigational.
Initiation of any DMT between the completion of apheresis and start of lymphodepletion (LD) chemotherapy. The use of methylprednisolone for bridging therapy between apheresis and start of LD chemotherapy will be allowed.
History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis or non-MS progressive neurologic condition affecting ability to perform study assessments.
Sequential
KYV-101 anti-CD19 CAR-T cell therapy
Biological/VaccineKYV-101 anti-CD19 CAR-T cell therapy
Standard lymphodepletion regimen
DrugStandard lymphodepletion regimen
Frequency of dose limiting toxicities at each dose level
Incidence of adverse events (AEs) including clinical tolerance and laboratory abnormalities
Clinical tolerance will be assessed with attention to cytokine release syndrome (CRS), Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) and other AE to be graded by CTCAE Version 5.0
To characterize the pharmacokinetics (PK)
Levels of KYV-101 CAR-positive T cells in the blood and cerebrospinal fluid from treatment baseline to end of study
To characterize the pharmacodynamics (PD)
Levels of B cells in the blood from treatment baseline to end of study
To evaluate clinical response
Time from CD19 KYV CAR T cell infusion to a change in disability and walking score, as measured by the Kurtzke Expanded Disability Status Scale (EDSS)
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Stanford University
Lead sponsor
Kyverna Therapeutics
Collaborator
