Active — Not RecruitingPhase 2

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

United States120 participantsStarted 2024-09-20

Plain-language summary

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Subject must have a history of diagnosis of primary progressive or secondary progressive MS.
✓. 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 within the 2 years prior to inclusion.

Exclusion criteria

✕. Monophasic disease, radiologically isolated syndrome, clinically isolated syndrome, progressive solitary sclerosis or relapsing-remitting disease as defined by the 2017 McDonald criteria.
✕. History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-MS progressive neurologic condition or PML.
✕. Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target
✕. History of allogeneic or autologous stem cell transplant
✕. Evidence of active hepatitis B or hepatitis C infection
✕. Positive serology for HIV
✕. Primary immunodeficiency
✕. History of splenectomy

What they're measuring

To evaluate efficacy of KYV-101

Timeframe: at least 12 weeks

Trial details

NCT IDNCT06384976

SponsorKyverna Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04

View on ClinicalTrials.gov More Multiple Sclerosis, Primary Progressive trials