This is an early exploratory study to assess the tolerability and safety of GC012F CAR T cell injection in Multiple Sclerosis patients.
a)Absolute neutrophil count ≥ 1.0 × 10^9/L (no growth factor is given for supportive care within 7 days prior to testing);
b)Absolute lymphocyte count ≥0.5×10^9/L;
c)Hemoglobin ≥ 80 g/L (no red blood cell transfusion is given within 7 days prior to testing);
d)Platelet count ≥ 50×10^9/L (no blood transfusion is given within 7 days prior to testing);
1.Fungal, bacterial, viral, or other infection not controlled and/or requiring hospitalization or intravenous antimicrobial therapy within 4 weeks prior to screening. Uncomplicated urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to current therapy;
2.Active tuberculosis or latent tuberculosis that has not been treated appropriately prior to screening;
3.History of severe hypersensitivity or allergy;
4.Primary immunodeficiency;
Single group
GC012F CAR-T Cell Injection
DrugA single dose group is planned for the CAR-T cell infusion dose is administrated for each subject.Single IV infusion.
Dose-Limiting Toxicity (DLT) Rate
DLT is defined as an AE that occurs within 28 days of GC012F CAR-T product reinfusion.DLT will be evaluated according to NCI-CTCAE V5.0 criteria.
Adverse Events （AEs）Rate
Proportion of trial participants experiencing AE within 15 years after infusion of GC012F CAR-T cell injection.
GC012F T cell count in peripheral blood and cerebrospinal fluid (CSF)(Pharmacokinetic evaluation indicators)
Maximum observed blood and CSF concentration, time to maximum observed blood and CSF concentration, area under the bloodand CSF concentration-time curve from time zero to 28 days after infusion, last observed measurable concentration, and time to last observed measurable CAR-T cell concentration
GC012F CAR gene copy number in peripheral blood and cerebrospinal fluid (CSF)(Pharmacodynamic evaluation indicators,)
Observe blood and CSF the highest concentration of the CAR gene copy number
Changes in the concentration of soluble B-cell maturation antigen (BCMA) in peripheral blood
Observe blood the highest concentration of the BCMA
Levels of Interleukins (IL-2, IL-6, IL-8, IL-10)
Observe blood the highest Quantification of the cytokines Interleukins (IL-2, IL-6, IL-8, IL-10)
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Daishi Tian
Lead sponsor
Tongji Hospital
Sponsor institution
