This is a global, multicenter, Phase 1b/2 study evaluating the safety and efficacy of C-CAR168, an autologous anti-CD20/BCMA chimeric antigen receptor T-cell therapy, in participants with progressive multiple sclerosis refractory to standard-of-care therapy. The study includes participants with secondary progressive multiple sclerosis (SPMS) and primary progressive multiple sclerosis (PPMS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
119
Autologous anti-CD20/BCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion following lymphodepleting chemotherapy.
Incidence and Severity of Treatment-Emergent Adverse Events
Incidence and severity of treatment-emergent adverse events, serious adverse events, dose-limiting toxicities, CRS, ICANS, adverse events of special interest, and treatment- or procedure-related adverse events.
Time frame: Through Month 24
Proportion of Participants With 6-Month Composite Confirmed Disability Progression (6m-cCDP) Through Month 12
Proportion of participants within each Phase 2 cohort experiencing 6-month composite confirmed disability progression through Month 12
Time frame: Through Month 12
Proportion of participants with 6m-cCDP - Through Month 12 (Phase 1b)
Time frame: Through Month 12 (Phase 1b)
Proportion of participants with 3m-cCDP
Time frame: Through Month 24
Proportion of participants with 6m-cCDP
Time frame: Through Month 24
Change from baseline in Expanded Disability Status Scale EDSS)
Time frame: Through Month 24
Change from baseline in Functional Systems Score (FSS)
Time frame: Through Month 24
Change from baseline in Timed 25-Foot Walk (T25FW)
Time frame: Through Month 24
Change from baseline in 9-Hole Peg Test (9-HPT)
Time frame: Month 12 and Month 24
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Time to first 3m-cCDP
Time frame: Through Month 24
Time to first 6m-cCDP
Time frame: Through Month 24
MRI lesion changes
Time frame: Through Month 24
Incidence and severity of adverse events and serious adverse events
Time frame: Through Month 24
Pharmacokinetics of C-CAR168 measured by quantitative polymerase chain reaction (qPCR)
Characterize CAR T-cell expansion and persistence using qPCR
Time frame: Through Month 24
Pharmacokinetics of C-CAR168 utilizing flow cytometry
Characterize T-cell expansion and persistence utilizing flow cytometry
Time frame: Through Month 24