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Trial Title:
KYSA-7: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis
NCT ID:
NCT06384976
Condition:
Multiple Sclerosis, Primary Progressive
Multiple Sclerosis, Secondary Progressive
Multiple Sclerosis
MS
Conditions: Official terms:
Neoplasm Metastasis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Conditions: Keywords:
KYV-101
multiple sclerosis
autoimmune disease
anti-CD19 CAR-T therapy
cellular therapy
MS
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
KYV-101
Description:
Anti-CD19 CAR-T cell therapy
Arm group label:
KYV-101 CAR-T cells with lymphodepletion conditioning
Intervention type:
Drug
Intervention name:
Standard lymphodepletion regimen
Description:
CYC/FLU
Arm group label:
KYV-101 CAR-T cells with lymphodepletion conditioning
Intervention type:
Drug
Intervention name:
Anti-CD20 mAB
Description:
Anti-CD20 mAB
Arm group label:
Anti- CD20 mAb
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
Detailed description:
Multiple sclerosis (MS) is an autoimmune and neurodegenerative disease in which
lymphocytes at first attack the myelin sheaths within the central nervous system (CNS),
accompanied or later followed by axonal damage. B cells play a central and
multifunctional role in the immunopathogenesis of MS. B cells present antigen to T cells
in stimulating a pro-inflammatory immune cascade, secrete pathogenic cytokines, moderate
T cell and myeloid cell functions, form structural B cell meningeal follicles within the
human central nervous system and produce pathogenic antibodies upon evolution to plasma
cells.
CD19-targeted chimeric antigen receptor (CAR) T cells harness the ability of cytotoxic T
cells to directly and specifically lyse target cells to effectively deplete B cells in
the circulation and in lymphoid and potentially non-lymphoid tissues. KYV-101, a fully
human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with
refractory primary and secondary progressive multiple sclerosis.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Subject must have a history of diagnosis of primary progressive or secondary
progressive MS.
2. 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.
Key Exclusion Criteria:
1. Monophasic disease, radiologically isolated syndrome, clinically isolated syndrome,
progressive solitary sclerosis or relapsing-remitting disease as defined by the 2017
McDonald criteria.
2. 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.
3. Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at
any target
4. History of allogeneic or autologous stem cell transplant
5. Evidence of active hepatitis B or hepatitis C infection
6. Positive serology for HIV
7. Primary immunodeficiency
8. History of splenectomy
9. History of stroke, seizure, dementia, Parkinson's disease, coordination movement
disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic
disorder investigator considers would increase the risk for the subject
10. Impaired cardiac function or clinically significant cardiac disease
11. Previous or concurrent malignancy with the following exceptions:
1. Adequately treated basal cell or squamous cell carcinoma (adequate wound
healing is required prior to screening)
2. In situ carcinoma of the cervix or breast, treated curatively and without
evidence of recurrence for at least 3 years prior to screening
3. A primary malignancy which has been completely resected, or treated, and is in
complete remission for at least 5 years prior to screening
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University Medical Center
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Start date:
September 2024
Completion date:
January 2029
Lead sponsor:
Agency:
Kyverna Therapeutics
Agency class:
Industry
Source:
Kyverna Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06384976
