multiple sclerosis
Conditions
Interventions
low dose group:Intravenous injection-induced amplification of autologous regulatory T cells (0.5×10^6 cells/kg)
middle dose group:Intravenous injection-induced amplification of autologous regulatory T cells (1×10^6 cells/kg)
high dose group:Intravenous injection-induced amplification of autologous regulatory T cells (2×10^6 cells/kg)
Dose Escalation Cohort:Intravenous injection-induced amplification of higher dose autologous regulatory T cells
Sponsors
Plastic Surgery Hospital, Chinese Academy of Medical sciences
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Age: 18–55 years (male or female); Diagnosis: Relapsing-remitting MS (RRMS) per 2017 McDonald Criteria; Disability Status: EDSS score 2–7 at screening/enrollment Disease Activity (for relapse after standard therapy, meet =1 of): >= 2 relapses in the 2 years pre-screening, >= 1 relapse in the 1 year pre-screening, >= 1 Gd-enhancing lesion on MRI in the 1 year pre-screening; Life Expectancy: >=12 weeks; Contraception: Agreement to use double-barrier methods during and 1 year post-study; Informed Consent: Signed written consent.
Exclusion criteria
Exclusion criteria: Organ Transplant: History of solid organ transplantation; Malignancy: Active malignancy within the past 2 years; Infectious Status (Positive for any of the following): HBsAg or HBcAb with detectable HBV DNA, HCV antibody with detectable HCV RNA, HIV antibody, CMV DNA, Syphilis serology (TPPA/RPR positive); Immunodeficiency: Congenital or acquired immunodeficiency; Cardiac Disease: Severe cardiovascular disorders; Psychiatric History: History of psychiatric disorders, Current use of psychotropic medications; Allergy: Atopic predisposition, History of severe hypersensitivity reactions; Autoimmune/Immunodeficiency: Concurrent diagnosis of other autoimmune or immunodeficiency diseases. Steroid Use: Glucocorticoid ("steroid") therapy within 3 months prior, Continuous steroid use for > 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Types and incidence of dose-limiting toxicity, DLT;annualized relapse rate, ARR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent of peripheral blood Foxp3+ CD4+ regulatory T cells;Number of T1 Gadolinium-Enhancing Lesions;Number of New or Enlarged T2 Lesions;Expanded Disability Status Scale;Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); | — |
Countries
China
Contacts
Public ContactGuangzhi Liu
Plastic Surgery Hospital, Chinese Academy of Medical sciences
Outcome results
None listed