About this trial
This is an early exploratory study to assess the tolerability and safety of GC012F CAR T cell injection in Multiple Sclerosis patients.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- GC012F CAR-T Cell Injection
Treatment groups
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and collaborators
Daishi Tian
Lead sponsor
Tongji Hospital
Sponsor institution