A study of alloHCT with Orca-Q for the treatment of primary progressive multiple sclerosis (MS).
Participants aged ≥18 and ≤65 years with primary progressive multiple sclerosis
A diagnosis of PPMS by 2017 McDonald criteria and 2013 clinical course revision102
CSF with elevated IgG index or 2 or more oligoclonal bands
EDSS (see Appendix 9) between 2.0 and 5.5 inclusive
History of Progressive Multifocal Leukoencephalopathy
Renal insufficiency as defined by an estimated GFR <60 mL/minute
Cardiac dysfunction as defined by symptomatic coronary artery disease, congestive heart failure, valvular heart disease, cardiomyopathy, uncontrolled arrhythmia(s), or left ventricular ejection fraction <50%. Participants with a history of these conditions may enroll if they are demonstrated to have optimal cardiac function (as defined by echocardiography or multi-gated acquisition scan)
Pulmonary dysfunction that poses a risk of mortality after transplant, defined as pre-transplant pulmonary function testing demonstrating a FEV1 <70% expected and/or a DLCOadj <70% expected.
Sequential
Orca-Q
Biological/VaccineAllogeneic (donor) stem cell graft
myeloablative regimen
DrugMyeloablative regimen of busulfan, fludarabine, and thiotepa.
Severe acute Graft-versus-Host-Disease-free survival
Alive without a history of moderate to severe aGVHD
Evaluate treatment response
Neurologically stable. Assessment of neurological function will be measured by employing the expanded disability status scale (EDSS)
Evaluate safety of treatment
Regimen-related toxicity, incidence and severity of GVHD, primary and secondary graft failure
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Stanford University
Lead sponsor
Orca Biosystems, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
