Finding studies
Finding studies
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Daishi Tian, Ph.D.
CONTACT
Lead
Daishi Tian
This is a single-arm, open-label, early exploratory clinical study to evaluate the safety and efficacy of GC012F Injection with or without Lymphocyte Depletion (LD) pretreatment in patients with MS, as well as to assess its PK and PD profiles. This study consists of the following periods: screening period, apheresis day, baseline period(if applicable), lymphodepletion preconditioning period, GC012F infusion, safety and efficacy follow-up period, and long-term follow-up period. This study consists of three phases: Stage A (Lymphocyte Depletion group ),stage B(Without (Lymphocyte Depletion group) and stage C (expansion period): Stage A (Lymphocyte Depletion group ):Three evaluable participants were enrolled and received a single dose CAR-T cell infusion, in combination with a Lymphocyte Depletion pre-treatment regimen, in order to establish the initial safety profile of this treatment. Stage B(Without Lymphocyte Depletion group) :Three evaluable participants were enrolled and received a single dose CAR-T cell infusion,in combination without a Lymphocyte Depletion pre-treatment regimen,To assess the necessity of combining Lymphocyte Depletion pre--treatment. stage C (expansion period):Enrolled up to 3 evaluable participants and received a single dose CAR-T cell infusion,According to the data of the early stage, consider whether to combine with Lymphocyte Depletion and pre-treatment. After the administration of GC012F, participants will be followed up for 3 years in this study, and then enter the long-term follow-up period to continue the long-term safety assessment and the persistence assessment of clinical response. The total follow-up period from the administration of GC012F is approximately 15 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
