This is an Early Exploratory Study to Assess the Tolerability and Safety of GC012F in Patients With Multiple Sclerosis

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaishi Tian

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

9 Participants
are divided into 1 treatment group

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & TechnologyRecruiting430030, Hubei, HubeiChinaChina

Sponsors and collaborators

Daishi Tian

Lead sponsor

Tongji Hospital

Sponsor institution